ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 5 June 2008 Application Code HSC08008 Application Type To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Epro Limited Applicant Purpose of the Application To import into containment GEDR on 1080 cereal bait for research to determine whether the addition of the deer repellent (GEDR) will alter the risk profile of the 1080 cereal bait with respect to non-target species (field trial). Date Application Received 10 April 2008 Consideration Date 5 June 2008 Considered by Rob Forlong, Chief Executive of ERMA New Zealand 1 Summary of decision 1.1 The application to field trial Green Epro Deer Repellent (GEDR) on 0.15% 1080 Pellets in the Rangitoto Range and Turangi Sector 2B is approved with controls as set out in Appendix 1. The approval has been made in accordance with the legislative criteria set out in Appendix 2. 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: GEDR on 0.15% 1080 Pellets (HSC08008) 2 Purpose of the application 2.1 The purpose of the application is to allow the manufacture of GEDR on 0.15% 1080 Pellets and the conduct of trials to determine whether the risk profile of the bait is changed in respect of endangering non-target species. 2.2 The proposed trials are to monitor effects of GEDR on 0.15% 1080 Pellets on tomtits and robins to provide data to support an application to ERMA New Zealand for release of the substance in New Zealand. The effects of the bait on the deer population will also be monitored. 3 Application process 3.1 The application was formally received on 10 April 2008. 3.2 Project Team: Noel McCardle Acting Applications Manager (Hazardous Substances) Sue Scobie Senior Advisor (Hazardous Substances) Linda Faulkner General Manager, Māori Unit Michael Morris Acting Reassessments Manager (Hazardous Substances). 3.3 The applicant supplied the following documents: the application; a report on the monitoring at Rotoaira (under Approval HSC000287); an Assessment of Environmental Effects for the Rangitoto Range operation; an Assessment of Environmental Effects for the VA003 (Turangi) Sector 2B operation. 3.4 The following government departments were advised of the receipt of the application (in accordance with clause 2(2)(e)) and given the opportunity to comment: The Ministry of Health; The Department of Labour; The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines Group (ACVM Group)); The Department of Conservation (DoC). 3.5 The applicant was provided with a copy of the proposed controls for the trials and given the opportunity to comment on them. The applicant did not make any comments on the controls. 4 Consideration Eligibility 4.1 As the purpose (see paragraphs 2.1 and 2.2) amounts to “research and development on any hazardous substance”, the Project Team considers that the application qualifies for consideration under section 30(ba). Lifecycle 4.2 Animal Control Products Limited will manufacture the uncoated pellets. The pellets will be transported from Wanganui to Epro Ltd by commercial truck transport in accordance with the relevant HSNO regulations and the Land Transport Rule – Dangerous Goods. ERMA New Zealand Decision: Application HSC08008 Page 2 of 10 4.3 The pellet baits will be coated with GEDR using a rotating auger. GEDR is a deer repellent formulation supplied by Epro Ltd. 4.4 The coated pellets are air dried before being bagged in helicopter loads. Flexible large is packaging used (woven nylon fadges) to hold treated pellets. These fadges will be loaded on to trucks at the Epro depot on the day of the operation before being transported to the helicopter loading sites located inside the treatment area. 4.5 Prefeeding of the trial area using non-toxic cereal bait, applied by helicopter with an under slung bucket at a rate of 2 kg/ha, will occur prior to application of the toxic bait. 4.6 Application of the pellet baits is expected to occur within 2 weeks of prefeeding, weather dependent. The proposed application rate is 2 kg/ha, by helicopter with under slung bucket. 4.7 Bait will be broadcast from a helicopter fitted with high precision navigational guidance equipment (GPS). The helicopter loading site is inside the containment area, and with the use of the GPS guidance system there is a very low risk of any bait being inadvertently applied outside the designated trial area. The boundaries of the trial area will be uploaded to the helicopter’s onboard navigational system prior to application, and the pilot will also fly a pre-operational visual inspection of the boundaries with the operational controller. 4.8 Approximately 25 tonnes of baits will be applied to 12,500 hectares of treatment area (approximately 6,300 hectares in the Rangitoto Range and 6,200 hectares on Turangi Sector 2B). 4.9 The bait will degrade in situ at a rate dependent primarily on rainfall. As the trial area is a high rainfall area, it is expected the baits will be effectively non-toxic within two months after application. 4.10 Unused bait will be transported by truck (or utility vehicle) back to the poison store at the local depot, for subsequent routine disposal by incineration. Hazardous properties 4.11 The Project Team notes that the understanding of the hazardous properties of the substance only needs to sufficient enough to ensure that any risks can be managed by the containment controls. 4.12 The Project Team notes that 0.15% 1080 cereal pellets are covered by the existing approval Cereal based pellets containing 1.5 - 2.0 g sodium fluoroacetate/kg (HSNO Approval Code: HSR002424). 4.13 These pellets were included in the Authority’s 2007 reassessment the approvals of formulated substances containing 1080 and as part of that reassessment were classified as follows: 6.1B acute oral toxicant; ERMA New Zealand Decision: Application HSC08008 Page 3 of 10 6.1C acute inhalational toxicant; 6.8A known reproductive toxicant; 9.1D slightly harmful to aquatic life; 9.3A highly toxic to terrestrial vertebrates. 4.14 The data provided by Epro Ltd. show that GEDR is non-hazardous. 4.15 The Project Team is satisfied that the use of GEDR on 0.15% 1080 cereal pellets will pose similar hazards to human health and the environment as are posed by the pellet baits. 4.16 Overall, the Project Team considers that the information provided by the applicant is sufficient to determine that any risks posed within the defined lifecycle of the substance in New Zealand can be managed through the application of controls. Identification and evaluation of the significant risks of the substance in containment 4.17 In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Project Team considered the potential risks of escape from containment under the headings of environmental, human health and welfare and Māori issues and concerns. 4.18 The following risk assessment takes into account the application of the controls that apply to 0.15% 1080 cereal pellet bait as a result of the 2007 reassessment of formulated substances containing 1080; the proposed containment controls; and controls in place under other legislation, such as the Resource Management Act 1991. 4.19 The Project Team also took into account the risk assessment undertaken by the Authority in considering the use of the same pellets in trials in Lake Rotoaira Forest and Turangi (application number HSC07024); and Mount Stalker and Beaumont Forest (application number HSC07044). Risks to the environment 4.20 The Project Team considers that, taking into account the controls that apply to the 0.15% 1080 cereal baits, the containment controls listed in Appendix 1, the other containment measures proposed by the applicant and controls in place under other legislation, the only potential environmental risks relate to exposure of non-target species at the trial site. These species include livestock who may feed on bait, dogs (through direct ingestion of bait or through secondary poisoning) and indigenous fauna (including birds). 4.21 The risks to livestock and dogs are managed by the consent conditions and standard HSNO controls on the use of substances containing 1080 and do not need to be considered any further for the purposes of this application. 4.22 The risks to native non-target species from the GEDR coated bait are uncertain, hence the need to conduct these field trials. The applicant has provided results from ERMA New Zealand Decision: Application HSC08008 Page 4 of 10 the November 2007 trials that indicate that the difference between areas treated with deer pellets and non-deer repellent pellets was not significant. 4.23 However, further trials are required to give confidence that the addition of deer repellent does not increase the risk profile of the pellets for native non-target species. 4.24 The proposed bird monitoring techniques set out in the application are similar to those used in previous trials (HSR07024). 4.25 While there is some residual risk to non-target species, and small passerine birds in particular from exposure to the GEDR treated pellets, given the scale of the trials and the ability of populations of these birds to recover relatively quickly from an impact, the Project Team considers that the benefits to be gained from the trial, ie more robust monitoring data, outweigh the risks. Risks to human health and welfare 4.26 The Project Team considers that, taking into account the existing controls that apply to the 1080 cereal baits, the containment controls listed in Appendix 1, the containment measures proposed by the applicant and controls in place under other legislation, there are no significant risks to human health and welfare. Relationship of Māori to the Environment 4.27 The Project Team notes that the applicant has consulted with the appropriate iwi/Māori organisations and interest groups about the containment proposal receiving support from Rereahu Regional Management Committee (RMC), Nehenehenui RMC and Ngati Tuwharetoa. None of the 7 organisations contacted raised any issues of concern. 4.28 Although there is some uncertainty relating to risks to native non-target species from the GEDR coating (as outlined in paragraphs 4.5 – 4.9) and therefore to the mauri of those species and ecosystems, the Project Team considers that the role of iwi/Māori as kaitiaki has been preserved by their ongoing involvement in operations of this kind. 4.29 In addition, the Project Team notes that the comprehensive monitoring regime proposed will provide information of significant benefit to iwi/Māori generally about the effects posed by the substance should it be the subject of a future release application under the Act (see control 16). 4.30 The Project Team considers that release beyond the contained areas is adequately managed by the nature of this ongoing dialogue with interested parties and the controls proposed for the trials will mitigate the risk of unintended release to negligible levels. 4.31 From the information provided, and considering that the application is for field trials, the Project Team considers that GEDR coated bait is unlikely to have an impact on the relationship between Māori culture and their traditions with their ERMA New Zealand Decision: Application HSC08008 Page 5 of 10 ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga. This is on the condition that the substance is used in accordance with the HSNO controls established for this application, and in accordance with any other relevant controls applying under other legislation. 4.32 However, should inappropriate or accidental use, transport or disposal of the substance result in the contamination of waterways and/ or land outside the containment areas, I recommend that the applicant notify the appropriate iwi land owner and or other iwi authorities in the region. This action should include advising them of the contamination and the measures taken in response. 5 Containment and controls 5.1 The Project Team has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and notes that these cover the matters set out in Part III of the Third Schedule of the Act, being: to limit the likelihood of escape of any contained hazardous substances or contamination by hazardous substances; to exclude organisms from a facility; to exclude unauthorized people from the facility; to prevent unintended release of the substances by experimenters working with the substance; to control the effects of any accidental release of the substance; inspection and monitoring requirements; and qualifications required of the person responsible for implementing the controls. 5.2 The Project team is satisfied that, with adherence to the controls listed in Appendix 1, including existing controls that apply to the 1080 cereal baits, the containment measures proposed by the applicant and those controls in place under other legislation, GEDR on 0.15% 1080 Pellets can be adequately contained. ERMA New Zealand Decision: Application HSC08008 Page 6 of 10 6 Conclusion 6.1 I have considered this application made under section 31 and, pursuant to section 32, I am satisfied that this application is for the purpose specified in section 30(ba), namely research and development on any hazardous substance. 6.2 Having considered the risks associated with the lifecycle of GEDR on 0.15% 1080 Pellets (HSC08008), I am satisfied that the controls imposed, including those in place under other legislation, will result in the substance being adequately contained. 6.3 The application to manufacture in containment the hazardous substances GEDR on 0.15% 1080 Pellets (HSC08008) is thus approved with controls in accordance with the relevant provisions of the Act and the Methodology as more specifically set out in Appendix 2. signed Rob Forlong Date: 5 June 2008 Chief Executive of ERMA New Zealand ERMA New Zealand Approval Code: GEDR on 0.15% 1080 Pellets (HSC08008) ERMA New Zealand Decision: Application HSC08008 HSC000332 Page 7 of 10 APPENDIX 1: LIST OF CONTROLS THAT APPLY TO THE HAZARDOUS SUBSTANCES, GEDR on 0.15% 1080 Pellets (HSC08008) 1. The manufacture of GEDR on 0.15% 1080 Pellets and the associated field trials shall be undertaken in accordance with the application. Modifications of the arrangements may be approved in writing by ERMA New Zealand providing that they comply with the following controls. 2. The controls that apply to Cereal based pellets containing 1.5 - 2.0 g sodium fluoroacetate/kg (HSNO Approval Code: HSR002424) under the Act apply to GEDR on 0.15% 1080 Pellets. 3. Notwithstanding the requirements of controls 1 and 2 above, the trials shall also comply with the following controls: 4. Access to the manufacturing facility shall be limited to authorised persons only. 5. The trials shall only be carried out at the locations identified by the applicant in the application as the field trial sites. 6. During storage, GEDR on 0.15% 1080 Pellets shall be kept in a locked storeroom at the premises. 7. The substance shall be transported in accordance with the Land Transport Rule (Dangerous Goods 2005) where applicable. A safety data sheet shall be kept with the substance during transport. 8. Any spillage of the substance during manufacture, transport (other than transport by helicopter) and storage shall be recovered and placed in bins, bags or buckets and returned to the manufacturer for disposal. 9. GEDR on 0.15% 1080 Pellets baits shall be dyed green. 10. Persons handling GEDR on 0.15% 1080 Pellets at any stage of its lifecycle, including cleaning up any spilt substance for disposal, shall wear suitable personal protective clothing. 11. The Department of Labour, [Attn. HSNO Project Manager (Workplace Group) P O Box 3705, Wellington], and ERMA New Zealand shall be informed in writing (by letter, fax or email) of the location, start, and completion of the trials. This notification shall be done at least 1 week, but not more than 2 months, before the start of the trial. Notifications shall include the following details: Substance name ERMA Application number ERMA Approval number ERMA Applications Advisor ERMA New Zealand Decision: Application HSC08008 GEDR on 0.15% 1080 Pellets HSC08008 HSC000332 Noel McCardle Page 8 of 10 12. If for any reason a breach of containment occurs, the Trial Director shall notify the Department of Labour and ERMA New Zealand within 24 hours of the breach being detected. It is suggested that if a breach in containment results in contamination of a waterway, the relevant iwi authorities be advised. 13. The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. 14. Bird monitoring shall be conducted as set out in section 2.2 of the application within the areas indicated on the maps provided with the application. 15. A full monitoring report shall be provided to ERMA New Zealand on completion of the trials. 16. A full monitoring report shall be provided to the 7 iwi/Māori organisations consulted in relation to this application (namely Rereahu RMC, Nehenehenui RMC, Te Tokanganui a Noho RMC, Tokaanu Marae, Waihi Marae, Ngati Tuwharetoa, Lake Rotoaira Forest Trust) on completion of the trials. 17. This approval remains in place until 31 December 2008. 18. A maximum amount of 25 tonnes of GEDR on 0.15% 1080 Pellets shall be applied to 12,500 hectares of treatment area (approximately 6,300 hectares in the Rangitoto Range and 6,200 hectares on Turangi Sector 2B). ERMA New Zealand Decision: Application HSC08008 Page 9 of 10 APPENDIX 2: LEGISLATIVE CRITERIA FOR THE APPROVAL A2.1 Unless otherwise stated, references to section numbers in this decision refer to sections of the Act and references to clauses refer to clauses in the Methodology A2.2 The application was lodged pursuant to section 31. The decision was made in accordance with section 32, taking into account additional matters to be considered in that section and matters specified under Part II of the Act (including the Methodology) and the provisions of Part III of the Third Schedule of the Act. A2.3 Government departments with an interest in this type of application were advised of the receipt of the application in accordance with clause 2(2)(e). A2.4 This application was considered by the Chief Executive of ERMA New Zealand under delegation from the Authority (section 19(2)(e)). A2.5 In accordance with section 32, the approach adopted when considering this application was to confirm whether the application was for one of the purposes specified in section 30, to identify and assess the risks (Clauses 9, 12, 13, 14, 22, 24, 25) and to determine whether the substance could be adequately contained by controls to provide for each of the matters specified in Part III of the Third Schedule of the Act. A2.6 In accordance with clause 36(2)(b), it is recorded that, in reaching his decision, the Chief Executive applied the criteria specified in section 32. A2.7 The Chief Executive also applied the following criteria in the Methodology: clause 11 – characteristics of substance; clause 21 – the decision accords with the requirements of the Act and regulations; clause 26 – all risks negligible; clause 35 – the costs and benefits of the controls. ERMA New Zealand Decision: Application HSC08008 Page 10 of 10