ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION Date Signed: 28 June 2004 Application code: NOC04007 Application category: Import into Containment any New Organism under section 40(1)(a) of the Hazardous Substances and New Organisms (HSNO) Act 1996 Company Animals on Q Private Bag 391 Picton 7372 Applicant: Purpose: The temporary importation of 8 grey wolf-dog hybrids into containment in New Zealand, for filming in several scenes in the major movie production, "The Lion, the Witch and the Wardrobe”. Date application received 20 April 2004 Consideration date: 11 June 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): Canis familiaris x lupis (“dog and grey wolf hybrid” or “wolf-dog hybrid”) 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 in 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 formally received and verified on 20 April 2004. In accordance with section 52 of the Act, the Authority requested further information from the applicant on the 21 and 28 April 2004. The application was un-stalled and processing recommenced on the 3 May 2004. Considerable additional information requests were made, and clarification sought of the information supplied, throughout the application process. The Committee noted that in many cases, the additional information supplied conflicted with the information supplied in the original application and had to be verified with the applicant. 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. As described in section 1.5 of the Evaluation and Review (E&R) Report, it was considered by the Chief Executive in consultation with the Chair of the NonGMO Standing Committee of the Authority that submissions would have been unlikely to contribute significantly to the Committee’s consideration of the application. The Committee noted that they had considered a similar application (NOC03003) to import into containment a bear for use in a movie and that application was also not notified. Consideration of the application was undertaken and completed on 11 June 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 E&R Report. Information Available for Consideration The documents available for the consideration of the application by the Committee were: Application NOC04007 (Form NO2N): To Import into Containment any New Organism that is not genetically modified and associated appendices. E&R Report prepared by the Agency to assist and support the Committee's decisionmaking. The E&R Report included as appendices subsequent information supplied by the applicant. Comments from MAF and DoC on the application. The application originally lodged was for wolf-dog hybrids and reindeer (Rangifer tarandus Linnaeus 1758). On 7 June 2004 the applicant advised ERMA New Zealand that they no longer planned to import reindeer. 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 members Dr Lin Roberts (Chair), Dr Max Suckling and Mr Tony Haggerty. Environmental Risk Management Authority Decision: Application NOC04007 Page 2 of 15 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 a self-sustaining population. Management techniques were considered in relation to the identified risks (clause 24) and those risks identified as significant were assessed (clause 12). Costs and benefits were assessed in accordance with clause 13 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) such other purposes as the Authority thinks fit. The purpose was modified from “The temporary importation of 20 highly trained animals, into containment in New Zealand, for filming in several scenes in the major movie production, "Lion Witch and the Wardrobe". The animals are 8 hybrids of dogs and grey wolves and 12 reindeer” to “The temporary importation of 8 -grey wolf-dog hybrids into containment in New Zealand, for filming in several scenes in the major movie production, "The Lion, the Witch and the Wardrobe” as reindeer were withdrawn from the application. The hybrid wolf-dogs will arrive at Auckland airport subject to the requirements of the relevant MAF Import Health Standards and permit issued by MAF. Each species will have approximately 10 days of filming with no more than 2 or 3 days at the outdoor location. They will remain in containment until re-exported from Auckland before the end of January 2005. The animals will be used to film in scenes of the motion picture “The Lion, the Witch and the Wardrobe”. Identification of Potential 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, the economy, Māori and their culture and traditions, human health and safety, society, and the community. 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: Adverse environmental effects In accordance with clauses 9(a)-9(c) and 10 of the Methodology, the Committee considered the risk of wolf-dog hybrids predating native ground-dwelling birds, lizards or introduced Environmental Risk Management Authority Decision: Application NOC04007 Page 3 of 15 domesticated, wild or feral mammals and birds. This is discussed further in section 6 of this decision. Adverse effects on the economy A “cost” is defined in clause 2 of the Methodology as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. The Committee considered costs that could be incurred by the approval of the application other than those to the applicant. The Committee noted that in the event that the wolf-dog hybrids escaped containment, there could be potential costs arising from recapture, if it was necessary to involve other groups in the search, e.g. the fire service or police. Adverse effects on Māori and their culture and traditions The Committee considered the potential cultural effects in accordance with clauses 9(b) and 9(c)(iv) of the Methodology and sections 5(b), 6(d) and 8 of the HSNO Act. This is discussed further in section 6 of this decision. Adverse effects on human health and safety The Committee identified that an adverse health effect on human health and safety due to members of the public, staff or trainers working with the animals becoming physically harmed if the wolf-dogs become aggressive or attack people was a potentially significant adverse effect in accordance with clauses 9 and 10 of the Methodology. This is further discussed in section 6 of this decision. Adverse effects on society and the community The Committee concurred with the E&R Report (section 3.6.2) that noted there were no significant potential adverse effects on the society and the community that were not more adequately described in the section of the E&R report entitled human health and safety. Beneficial effects 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. Further discussion of the benefits noted in section 3.8.1 of the E&R Report is noted in section 6 of this decision. 5 Adequacy of the Proposed Containment Regime In carrying out its consideration the Committee noted 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. Environmental Risk Management Authority Decision: Application NOC04007 Page 4 of 15 Ability to adequately contain the organism In considering the ability of the organism to escape from containment, the Committee considered the: i. biological characteristics of the organism ii. proposed containment regime iii. potential pathways for escape of organism from the containment facility iv. ability of the organism to establish a self-sustaining population. (i) Biological characteristics of the organism The Committee noted Table 2 (section 2.22) of the E&R Report gave the parentage of each of the wolf-dog hybrids. The wolf-dog hybrid Canis familiaris x lupus is a cross between Malamute (husky) dogs (Canis familiaris) and the Eastern Timber Wolf (Canis lupus). The Malamute dog is not a new organism to New Zealand. However, the eastern timber wolf is. The Committee also noted that the dog called Rio, referred to in Table 2 (section 2.22) of the E&R Report is an entire 10 year old male and is the result of first generation cross between Malamute (Canis familaris) and a grey wolf (Canis lupus). Rio is therefore a new organism, and requires consideration by the Committee. The Committee also noted that Rio is not neutered. The applicant noted subsequent correspondence to the E&R Report “the applicant would prefer not to have to hormonally sterilise him because the side effects of the treatment may make it more difficult to get Rio to perform. He is a highly trained 10 year old dog with a lifetime history of obedient behaviour and the applicant would argue that the probability of him escaping and mating with a local bitch is very low”. (ii) Proposed containment regime The proposed containment was outlined in section 4.2 of the E&R Report. The Committee noted that there are three different containment arrangements in place for the duration of the stay of the wolf-dog hybrids in New Zealand. 1. Mark Vette’s Rescue Zoo. 2. Indoor filming locations (3). 3. Outdoor filming locations (2). The Committee noted the applicant’s request to keep the exact locations of the containment facilities confidential. The Committee noted that each filming location (both indoor and outdoor) and Mark Vette’s Rescue Zoo would need to be registered as containment facilities by MAF. The wolf-dog hybrids are to be kept in containment that meets the requirements of the MAF/ERMA Standard 154.03.04 Containment Facilities for Zoo Animals. This Standard has requirements for substantial fencing for zoo animals (1.8 metre). These specific fencing requirements are waived for circus animals. The Committee notes that animals taking part in films are similar Environmental Risk Management Authority Decision: Application NOC04007 Page 5 of 15 to circus animals in that they are not kept on permanent display but are travelling animals used for entertainment. Section 4.2.3 of the Standard allows for an alternative to the 1.8 metre fencing. “The requirement for perimeter fencing is waived for circuses ‘on the road' but measures to protect the public from zoo animals shall be implemented. These shall include the use of temporary fences at least 0.9 metres high and direct supervision by circus staff”. The Committee considered that when MAF inspect the facilities, they will need to ensure containment is adequate to prevent escape of the wolf-dog hybrids. The Committee also noted (section 4.2.7 of the E&R Report) that prior to movement out of quarantine the animals will be examined for general health and fitness in consultation with MAF. This inspection will include having the relevant health certification papers for the animals. A MAF Biosecurity Authority authorisation will also be obtained prior to transportation. Once the above has been completed the animals will move by trailer and road to the filming locations. The Committee also considered containment at the filming locations. The Committee noted section 4.2.10 of the E&R Report that outlined that each of the filming sites will be registered by MAF as a containment facility under the MAF/ERMA New Zealand Standard 154.03.04 Containment Facilities for Zoo Animals. When registering each location, MAF will ensure compliance with the controls specified by the Authority. The MAF/ERMA New Zealand Standard 154.03.04 requires that “approval may be given for the temporary transfer of animals outside the zoo for any legitimate purpose (veterinary treatment, educational, filming or exhibition) but the national manger must be satisfied that the provisions for containment are addressed. The operator shall submit a proposal that provides details of the containment provisions associated with the transport and the temporary holding enclosure”. The Committee also considered containment of the wolf-dog hybrids while filming on-set (section 4.2.12- 4.2.18 of the E&R Report). The Committee noted that the wolf-dog hybrids were highly trained animals that have been trained to stay within fences. It was also planned to have 8 handlers, one for each wolf-dog hybrid while filming was being undertaken. The wolf-dog hybrids were also to be individually tethered except while rehearsing or filming. The Committee noted that the applicant has advised that the trainers will have appropriate techniques and equipment to subdue each animal (including sound aversion sirens, nets, nooses and special leads) if animals should become difficult to manage. As well, the trainers will have been trained in the use of, and have available on set, a tranquillizing hypodermic dart gun, in case any animals attempt to leave the set, or become unmanageable or aggressive. (iii) Potential pathways for escape of organism from the containment facility The Committee noted section 4.4 of the E&R Report. The Committee noted that the wolf-dog hybrids were highly trained and therefore valuable animals and also that they were operating in a high security environment. The Committee noted the contingency plans (as outlined in section 4.4.10 of the E&R Report) that the applicant had proposed in the event of escape of one or more of the wolf-dog hybrids and noted that these must be supplied to MAF. The Committee imposed additional control 5.3 “The extent of the containment area identified by the electric fence approved by the Ministry of Agriculture and Forestry and a site map identifying this fenced area shall be provided to the Ministry of Agriculture and Forestry prior to the wolf-dog hybrids being introduced to an electric fence area. The electric fence Environmental Risk Management Authority Decision: Application NOC04007 Page 6 of 15 shall be labelled with prominent warning signs to prevent unauthorised or unintentional access to the containment area.” The Committee considered that this would prevent the escape of the wolf-dog hybrids and also prevent unauthorised or unintentional access to the containment area. The Committee concurred with the assessment given in the E&R Report (section 4.5) that the likelihood of escape of the wolf-dog hybrids was improbable. (iv) Ability of the organism to establish a self-sustaining population The Committee noted that Rio had the ability, if he escaped, to mate with other dogs. But, the Committee noted that escape was considered improbable and that the wolf-dog hybrids were unlikely to be free long enough for the dog to come into contact with a receptive female. 6 Assessment of Potential 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. The Committee noted all the potential adverse and beneficial effects discussed in section 5 of the E&R Report. The Committee then chose to focus their discussion on the potential adverse effects which they considered to be most significant. Adverse effects to the environment The Committee records that risks to the environment were considered, in accordance with clauses 9(a)-9(c) and 10 of the Methodology. The Committee considered the risk of wolf-dogs hybrids predating native ground-dwelling birds, lizards or introduced domesticated, wild or feral mammals and birds. The Committee considered that it is improbable that the wolf-dog hybrids will escape, that detection following escape is likely to be immediate and that the Committee considers the applicant’s contingency planning in event of escape to be adequate. Also, the Committee noted that the animals have been reared by humans and are not used to foraging for their own food. Therefore, the Committee considered the potential risks to the environment as a result of a wolf-dog hybrid escaping and predating native ground-dwelling birds, lizards or introduced domesticated, wild or feral mammals and birds to be negligible. Potential adverse effects on the economy The Committee records that adverse effects to the economy were considered, in accordance with clauses 9(a)-9(c) and 10 of the Methodology. Environmental Risk Management Authority Decision: Application NOC04007 Page 7 of 15 The Committee noted section 3.4.1 of the E&R Report. The Committee noted that should a wolf-dog hybrid escape, any cost as a result of this should be incurred by the applicant and not by the general community. As it is considered to be improbable that wolf-dog hybrids will escape, the Committee considers the potential risks to the economy to be negligible. Adverse effects on Māori The Committee records that risks to Māori culture were considered in accordance with sections 6(d) and 8 of the Act and clauses 9(b)(i) and 9(c)(iv) of the Methodology. The Committee considers that in the event of escape, the adverse effect to the relationship of Māori with their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga would be minor. The Committee considered the potential risks to Māori to be negligible. Adverse effects to society and the community The Committee considers that there are no significant potential adverse effects on the society and the community that are not more adequately described in other sections of this decision. Adverse effects to human health and safety The Committee considered the adverse health and safety effects of the wolf-dog hybrids escaping, coming into contact with the general public and causing physical harm (e.g. biting or scratching) in accordance with clauses 12, 13 and 14 of the Methodology. The Committee noted the containment regime and in particular that the applicant has advised that they will ensure that people that come into contact with the animals while on the film set are aware of the risks by: Posting notices on the containment fencing alerting people to the dangers of crossing into the containment area. Ensuring adequate security around the containment area. Ensuring that members of the public are not able to enter the site and that all approved visitors will be subject to site OSH requirements, including details of how to avoid risks with the animals. There will also be a very substantial site security team to protect the actors as well as the animals and to protect the commercial secrecy of the project. The applicant will ensure that a regular briefing is given to people on set to ensure safety for both animals and people while filming. The Committee noted that the containment regime is designed to prevent anyone coming into contact with the wolf-dog hybrids without authorisation. In addition, the Committee noted that the dogs are highly trained animals and accustomed to being around people. The Committee considered there was a risk that the wolf-dog hybrids may become uncontrollable during filming. The Committee noted that each animal would have an individual trainer and Environmental Risk Management Authority Decision: Application NOC04007 Page 8 of 15 the Committee was satisfied that the trainers will have appropriate techniques and equipment to subdue the wolf-dog hybrids (including sound aversion sirens, nets, nooses and special leads) if animals should become difficult to manage. The Committee notes that the applicant intends that the trainers will have been trained in the use of (and have available on set) a tranquillizing hypodermic dart gun, in case any animals attempt to leave the set, or become unmanageable or aggressive. Appropriate drugs will be available to sufficiently sedate the animals so they can be moved back into the trailer containment facility, as outlined in additional control 5.2 . The Committee noted the extensive experience that the trainers have had dealing with a wide variety of animals and the trained nature of the animals. The Committee concurred with the E&R Report (section 5.7.6) and considered that the wolf-dog hybrid presented more of a risk to human health and safety in the event of escape than in containment. The wolf-dog hybrids are well monitored and a trainer will be available to subdue the animals if they become distressed or difficult to handle. In the event of escape from containment, the wolf-dog may become stressed and more likely to use aggressive defensive behaviour, particularly if provoked. The degree of uncertainty attached to the evidence has been taken into account, as required under clauses 25(1), 29, 30, 32 and 33 of the Methodology. The Committee noted a high degree of uncertainty surrounding the magnitude of an adverse effect. The Committee considered that the containment control regime is important to ensure that the wolf-dog hybrids do not escape containment. The Committee considered that the wolf-dog hybrids should be monitored at all times, therefore, if escape did occur an alarm could be raised immediately. The Committee noted that the applicant has not yet finalised selection of a humane society representative. However, the Committee notes the applicant is required to comply with the requirements of the New Zealand Animal Welfare Act 1999. Assessment of Costs A “cost” is defined in clause 2 of the Methodology 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. However, as noted above, should a wolf-dog hybrid escape any cost as a result of this should be incurred by the applicant and not by the general community. Assessment of benefits (beneficial effects) A “benefit” is defined in clause 2 of the Methodology 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 of the Methodology were considered in terms of clause 13. The Committee noted that the benefits would be considered moderate to major and furthermore, that the benefits would have a ‘trickle down’ effect that may last sometime. The Committee noted that there was a degree of uncertainty surrounding how large the benefits would be. Environmental Risk Management Authority Decision: Application NOC04007 Page 9 of 15 7 Establishment of the Approach to Risk in the Light of Risk Characteristics Clause 33 of the Methodology requires the Authority to have regard to 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, the containment measures limit the extent to which exposure to the risks is involuntary. The Committee also considered that there were no significant risks which are not known or understood by the general public. Given the Committee's finding that the risk of escape of the wolf-dog hybrids occurring is improbable, the extent to which these risk characteristics are present does not warrant caution additional to that required by section 7 of the Act. 8 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 human health and safety. More specifically, that wolf-dog hybrids may become aggressive and attack people. The Committee made the decision under clause 27 of the Methodology as it did not consider that the risks to human health and safety were negligible. The Committee also considered the uncertainty surrounding the magnitude of the potential adverse effects to human health and safety, and that ensuring containment and safety procedures were adequate was of paramount importance. The Committee considered all of the controls, set out in Appendix 1 of the E&R Report and did so in the context both of preventing the escape of the organism, 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. 9 Decision 1. Pursuant to section 45(1)(a)(i) of the HSNO Act, the Committee is satisfied that this application is for one of the purposes specified in section 39 (1) of the Act, being section 39(1)(h) such other purposes as the Authority thinks fit. Having considered all the possible effects of the organism in accordance with sections 45(1)(a)(ii) and 44 of the Act 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 associated with the Environmental Risk Management Authority Decision: Application NOC04007 Page 10 of 15 importation into containment of the following organism are outweighed by the benefits: Canis familiaris x lupis 2. The Committee is satisfied that the proposed containment regime, as set out in Appendix 1 of this decision, will adequately contain the organism for the purposes of section 45(1)(a)(iii) of the HSNO Act. 3. In accordance with clause 36(2)(b) of the Methodology the Committee records that, in reaching this decision, it has applied the balancing tests in section 45 of the HSNO Act 1996 and clause 27 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. 4. 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 HSNO 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 are and costs are outweighed by benefits; clause 33 – the risk characteristics; and clause 34 – the aggregation and comparison of risks, costs and benefits. Environmental Risk Management Authority Decision: Application NOC04007 Page 11 of 15 The application for importation into containment of Canis familiaris x lupis is thus approved, with controls, as set out in Appendix 1 of this decision. Dr Lin Roberts Chairperson of Decision-making Committee Date Organism approval code: NOC002284 Environmental Risk Management Authority Decision: Application NOC04007 Page 12 of 15 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 organism (Canis familiaris x lupis) is subject to the following controls: 1 To limit the likelihood of any accidental release of any organism or any viable genetic material2: The organism shall be imported into and maintained in a containment facility that complies with these controls: 1.1 The person responsible for the operation of the containment facilities (‘the facilities’) shall inform all personnel involved in the handling of the organism of the Authority’s controls. 1.2 The facility shall be approved by Ministry of Agriculture and Forestry (MAF), in accordance with the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.04: Containment Facilities for Zoo Animals and additional controls of the Authority. 1.3 The operation and management of the containment facilities shall be in accordance with the MAF/ERMA New Zealand Standard 154.03.04: Containment Facilities for Zoo Animals and the additional controls of the Authority. 2 To exclude unauthorised people from the facility: 2.1 The identification of entrances, numbers of and access to entrances, and security requirements for the entrances and the facilities shall be in compliance with the requirements of the Standard listed in control 1.2 and the additional controls of the Authority. 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 Standard listed in control 1.2. 3.2 If for any reason a breach of containment occurs, the facilities Supervisor, MAF Biosecurity Authority and ERMA New Zealand shall promptly be notified as soon as is practicable after the event is noticed. 1 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. 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. 3.3 In the event of any breach of containment that results in the escape of the organism subject to this approval, a contingency plan for the attempted retrieval or destruction of the organism shall be implemented immediately. The contingency plan shall be included in the Containment Manual in accordance with the Standard listed in control 1.2. 3.4 The applicant shall comply with the requirements of the Standard listed in control 1.2 relating to the maintenance of records demonstrating compliance with the Standard, as required by the quality assurance programme, and documented in the Containment Manual. 4 Inspection and monitoring requirements for containment facilities: 4.1 The inspection and monitoring requirements for the containment facilities shall be in compliance with the Standard listed in control 1.2. 4.2 The Authority, or its authorised agent or properly authorised enforcement officers, may inspect the facilities at any reasonable time. 4.3 The Containment Manual shall be updated, as necessary, to address the implementation of the controls imposed by this approval, in accordance with the Standard listed in control 1.2 and the additional controls of the Authority. 4.4 The training of personnel working in the facilities shall be in compliance with the Standard listed in control 1.2. 5 Additional controls: 5.1 The organisms subject to this approval must leave New Zealand no later than 31 January 2005. 5.2 The organisms shall remain at all times in one of the following registered containment facilities, to be approved by MAF, until the animals are exported from New Zealand: 5.3 a) At Mark Vette’s rescue zoo (‘home base’); or b) An indoor filming location accompanied by an appropriate number of trainers and a sentry equipped with a tranquilising dart gun posted to monitor and if necessary immobilise any animal if it breaches the containment area; or c) A locked cage/trailer with security guard(s) present; or d) An outdoor filming location surrounded by an electric fenced area in accordance with the Standard and in which the wolf-dog hybrids shall at all times be accompanied by trainers and a sentry equipped with a tranquilising dart gun posted to monitor and if necessary immobilise any animal if it breaches the containment area identified by the electric fence. The extent of the containment area identified by the electric fence approved by the Ministry of Agriculture and Forestry and a site map identifying this fenced area shall be Environmental Risk Management Authority Decision: Application NOC04007 Page 14 of 15 provided to the Ministry of Agriculture and Forestry prior to the wolf-dog hybrids being introduced to an electric fence area. The electric fence shall be labelled with prominent warning signs to prevent unauthorised or unintentional access to the containment area. Environmental Risk Management Authority Decision: Application NOC04007 Page 15 of 15