ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 12 September 2007 Application Code HSC07024 Application Type To import or manufacture hazardous substances in containment under Section 31 of the Hazardous Substances and New Organisms Act 1996 Applicant Animal Health Board Purpose of the Application To field trial by aerial distribution, Green Epro Deer Repellent (GEDR) on 1080 Cereal Bait, to determine whether the risk profile of the cereal bait is changed in respect of endangering non-target species Date Application Received 10 September 2007 Consideration Date 11 September 2007 Considered by A Committee of the Authority (“the Committee”) 1 Summary of Decision 1.1 The application to field trial by aerial distribution, Green Epro Deer Repellent (GEDR) on 1080 Cereal Bait, is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (“the Act”) and the HSNO (Methodology) Order 1998 (“the Methodology”). 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 2 Legislative Criteria for Application 2.1 The application was lodged pursuant to section 31. The decision was determined in accordance with section 32, taking into account additional matters to be considered in that section and matters relevant to the purpose of the Act, as specified under Part II of the Act and the provisions of Part III of the Third Schedule of the Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the Act. 2.2 Consideration of the application followed the relevant provisions of the Methodology. Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology. 3 Application Process 3.1 The application was formally received on 10 September 2007. 3.2 Project Team: Noel McCardle Senior Advisor (Hazardous Substances) Sue Scobie Senior Advisor (Hazardous Substances) Linda Faulkner General Manager, Māori. Report review and sign-out by: Dr Peter Dawson Principal Scientist (Hazardous Substances). 3.3 The applicant supplied the following documents: The application; Research Reports; Assessments of Environmental Effects (AEEs); Bird Monitoring Maps. 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 Department of Conservation the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines Group (ACVM Group)). 3.4.1 3.5 The Department of Conservation commented that Fantails and Tomtits are absolutely protected species under the Wildlife Act 1953. However, there are no issues with this as this is an observational study with no manipulation or invasiveness using standard pest control techniques (apart from the deer repellent), and the trial has high conservation relevance which should be supported. The applicant was provided with a copy of the proposed controls for GEDR on 0.15% 1080 Pellets and given the opportunity to comment on them. The comments received from the applicant were taken into account when considering this application. 4 Consideration Sequence of the Consideration 4.1 The following members of the Authority’s Hearings Committee considered the application in accordance with a delegation under section 19(2)(b)): Mr Neil Walter (Chair), Professor George Clark, Dr Manuka Henare and Ms Helen Atkins. 4.2 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 associated with the application and to ERMA New Zealand Decision: Application HSC07024 Page 2 of 11 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. Purpose of the Application 4.3 As GEDR on 0.15% 1080 Pellets is a new hazardous substance within the meaning of the Act, it will require an approval under the Act before it can be released. The purpose of this containment application is to allow the manufacture of the new formulation in containment and the conduct of trials to determine whether the risk profile of the cereal bait is changed in respect of endangering non-target species. 4.4 The Committee notes that such research on any hazardous substance to acquire information for use in assessing that substance in accordance with the Act qualifies for consideration under section 30(b). Lifecycle 4.5 Animal Control Products Limited will manufacture the uncoated pellets. The pellets will be transported from Wanganui to Epro Taupo by commercial truck transport in accordance with the relevant HSNO regulations and the Land Transport Rule – Dangerous Goods. 4.6 The pellet baits will be coated with GEDR using a rotating auger. GEDR is a deer repellent formulation supplied by Epro Ltd. GEDR will be sprayed into the pellets as they travel up the elevating auger. Movement of the pellets as they travel up the auger will be sufficient to completely coat each pellet. 4.7 The baits will then be air dried before being bagged in helicopter loads. The flexible large packaging used to hold treated pellets is approved as large packaging as required under Part 2A of the Hazardous Substances (Packaging) Regulations 2001. These bags 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. The bags are tied closed at the top to prevent accidental spillage. 4.8 Prefeeding of the trial area using non-toxic cereal bait, applied by helicopter with an under slung bucket at a rate of 2kg/ha will occur prior to application of the toxic bait. 4.9 Application of the toxic bait is expected to occur within 2 weeks of prefeeding, weather dependent. Application rate is 2 kg/ha, by helicopter with under slung bucket. 4.10 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 in 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. 4.11 Approximately 18 tonnes of GEDR 1080 pellets will be applied to 9000 hectares of treatment area. The GEDR trial sites are smaller blocks within a much larger aerial 1080 Tb vector control operation which has been in progress since early July 2007. ERMA New Zealand Decision: Application HSC07024 Page 3 of 11 These sites are as marked on the map provided in the application. The larger operation in its entirety has been granted the necessary resource consent from Environment Waikato and permissions as required from the Medical Officer of Health and the Department of Conservation. 4.12 The GEDR trial sites are located on Lake Rotoaira Forest Trust land, which incorporates a mix of mature pine/cypress with manuka shrubland, mature and regenerating beech/hardwood forest. 4.13 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 2 months after application. 4.14 Unused bait will be transported by truck (or utility vehicle) back to the poison store at the Epro Depot at Taupo, for subsequent routine disposal by incineration. 4.15 Large packaging is returned to the Epro Depot and reused. The multi-wall paper bags used to hold the pellets before treatment with GEDR and any small amounts of unused bait on completion of the operation will be burned in an industrial incinerator at the Epro Depot at Taupo. Hazardous Properties 4.16 The 0.15% 1080 cereal pellets are covered by the approval Cereal based pellets containing 1.5 - 2.0 g sodium fluoroacetate/kg (HSNO Approval Code: HSR002424). 4.17 These pellets were included in the reassessment of substances containing 1080 and as part of the reassessment were classified as follows: 6.1B acute oral toxicant; 6.1C acute inhalational toxicant; 6.8A known reproductive toxicant; 9.1D slightly harmful to aquatic life; 9.3A highly toxic to terrestrial vertebrates. 4.18 The data provided by EPRO Ltd. show that GEDR is non-hazardous. 4.19 The Committee is satisfied that the GEDR on 0.15% 1080 Pellets combination of the pellet baits and GEDR, will pose similar hazards to human health and the environment as are posed by the pellet baits. Identification and evaluation of the significant risks of the substance in containment 4.20 In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Committee considered the potential risks of escape from containment under the headings of environmental, human health and welfare and Māori issues and concerns. 4.21 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 reassessment of substances ERMA New Zealand Decision: Application HSC07024 Page 4 of 11 containing 1080; the proposed containment controls; and controls in place under other legislation, such as the Resource Management Act 1991. 4.22 In this regard, the Committee notes that all necessary consultation has been undertaken with the owners of the trial sites and adjacent landowners, along with other interested parties associated with the whole operation. This information is documented as Appendix 2 of the AEE for Lake Rotoaira Forest and Appendix 3 for the AEE for Turangi Sector 5A. Risks to the Environment 4.23 The Committee considers that, taking into account the 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, 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). 4.24 The risks to livestock and dogs are managed by the consent conditions and standard HSNO controls on the use of substances containing 1080 and are not considered any further for the purposes of this application. 4.25 The risks to native non-target species from the GEDR coated bait are uncertain, hence the need to conduct the field trials. The applicant has provided a number of references which suggest that the risks to tomtits and robins are no greater than for non-GEDR treated cereal pellets; however, adequate monitoring has not been conducted on the scale proposed in this application. 4.26 Details of the proposed bird monitoring are included in the application on pages 3-5. The Agency notes that while the initial proposal was to monitor both robins and tomtits as the birds most vulnerable to 1080 pellets, a recent site inspection by the contractor undertaking the monitoring indicates that there are probably insufficient numbers of robins present on the GEDR treatment sites. Therefore, the monitoring will focus on tomtits. Non-treatment sites and areas treated with standard 0.15% 1080 cereal sites will also be monitored to provide for comparison of results across treatments. The Agency envisages that further field trials may be required to extend the range of habitat types and number of species being monitored. 4.27 Table 1 shows a summary of the work to date on Epro Deer Repellent (EDR) and GEDR deer repellents. It is noted that EDR has been used on carrot bait and has previously been trialed without HSNO approval on cereal bait (e.g. Lorigan 2006; Morriss et al 2006). The EDR turned the cereal pellets brown rather than green as required by the controls on substances containing 1080. Therefore, GEDR was developed and when it is applied to cereal pellets the bait remains green. ERMA New Zealand Decision: Application HSC07024 Page 5 of 11 Table 1 Summary information: trials on effects of EDR and GEDR deer repellents in target and non-target species Species being monitored and location of trials Bait type and application rate Summary of results Reference as listed in bibliography to the application North Island brown kiwi Apteryx australis [captive birds: two adults, four juveniles] Non-toxic carrot and cereal bait treated with EDR Baits presented at 500 to 1000 times greater than standard 1080 operation Some kiwi investigated the baits but no baits were eaten during four hours of observation using night vision equipment over four separate nights. Speedy CJT 2003 Robins (Petroica australis) Tomtits (Petroica macrocephala) Lake Taupo Forest 0.08% 1080 Carrot surface coated with EDR sown at 5 kg/ha No statistically significant differences in bird density. Significant difference between robin populations in treatment and control areas, due to unexplained decreases in the control population [possibly severe weather events and other disturbances] Oates 2006 Robins (Petroica australis) Tomtits (Petroica macrocephala) Free-ranging birds in field not previously exposed to baits Non-toxic carrot and cereal bait containing cinnamon and treated with EDR, with and without green dye; freshly treated and weathered baits both used No significant differences in the number of pecks at bait with or without EDR irrespective of age of bait. Significantly less carrot bait with repellent was pecked at by robins than carrot without repellent EDR irrespective of age of bait. Only half as much cereal bait was consumed by robins as carrot due to more dense texture when dry Robins frequently pecked baits; tomtits did not interfere with any bait treatments Ross et al 2006 Tomtits (Petroica macrocephala) Aorangi Forest Park, Wairarapa 9800 ha 0.08% 1080 Carrot surface coated with EDR sown at 5 kg/ha No significant decrease in tomtit abundance between EDR treated areas and non-EDR treated toxic bait; no nontreatment sites Notes that results should not be extrapolated to other bird species Ross 2007 Farmed red deer Six non-toxic cereal bait types in combination with cinnamon lure and/or deer repellent [EDR] Intensively farmed deer ate very little cereal bait surfaced coated with EDR both with and without cinnamon lure but ate all bait with no repellent or with repellent incorporated into the bait – stag ate bait faster than hinds Extensively farmed deer ate little bait of any type until 4th day, with stags eating more non-repellent than repellent coated baits Morriss et al 2003 Wild red deer – Hampden Otago 800 ha treated with 1080 carrot surface coated with EDR Too few deer available in the trial areas to allow robust assessment of effectiveness and lack of replication Lorigan and Nugent 2002 Wild red deer – Tataraakina, Hawkes Bay 2000 ha treated with 1080 carrot surface coated with EDR Deer repellent reduced mortality in repellent block to near 0 compared with non-repellent block with estimated kill of >50% Nugent et al 2004 Birds Deer ERMA New Zealand Decision: Application HSC07024 Page 6 of 11 Species being monitored and location of trials Bait type and application rate Summary of results Reference as listed in bibliography to the application Wild red deer – Hawkes’ Bay 1074 ha cereal bait treated with EDR Deer repellent reduced mortality in repellent block to near 0 compared with non-repellent block with estimated kill of 59% Recommendation for further field trials to include more intensive and quantitative monitoring of non-target native species Morris et al 2006 Possums See above In the above trials, EDR on carrot or cereal had no impact on efficacy against possums See above Rodents – Otupua stream headwaters, tributary of Mohaka River 0.15% 1080 Cereal bait treated with EDR sown at 2 kg/ha Summer application of bait may limit conclusions which can be drawn for more usual winter operations. Tracking abundance significantly reduced at treatment sites relative to non-treatment areas Replication required under winter conditions Lorigan 2006 Target pests 4.28 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 Committee considers that the benefits to be gained from the trial, ie robust monitoring data, outweigh the risks. Risks to Human Health and Welfare 4.29 The Committee considers that, taking into account the 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 4.30 The Committee notes that the applicant has consulted with the appropriate iwi/Māori land owners and interest groups about the containment proposal receiving support and interest in ongoing involvement. Although there is some uncertainty relating to risks to native non-target species from the GEDR coating (as outlined in section 4.25) and therefore to the mauri of those species and ecosystems, the Committee considers that the role of iwi/Māori as kaitiaki has been preserved by their ongoing involvement in this containment trial. 4.31 In addition the Committee 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. ERMA New Zealand Decision: Application HSC07024 Page 7 of 11 4.32 The Committee considers that release beyond the contained areas is adequately managed by the nature of this ongoing dialogue with interested parties and the standard and suggested controls proposed for the trial will mitigate the risk of unintended release to negligible levels. 4.33 From the information provided, and considering that the application is for field trials, the Committee considers that GEDR on 0.15% 1080 Pellets is unlikely to have an impact on the relationship between Māori culture and their traditions with their 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. 4.34 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, it is suggested 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 5.2 The Committee has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and note 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 substances; to control the effects of any accidental release of the substances; inspection and monitoring requirements; qualifications required of the person responsible for implementing the controls. The Committee is satisfied that, with adherence to the controls listed in Appendix 1, including 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. 6 Decision 6.1 The Committee has considered this application made under section 31, and pursuant to section 32, the Committee is satisfied that this application is for the purpose specified in section 30(b) (research on any hazardous substance to acquire information for use in assessing that substance in accordance with the Act). 6.2 Having considered the risks associated with the lifecycle of GEDR on 0.15% 1080 Pellets, the Committee is satisfied that the controls imposed, including those in place under other legislation, will result in the substance being adequately contained. ERMA New Zealand Decision: Application HSC07024 Page 8 of 11 6.3 In accordance with clause 36(2)(b), the Committee records that, in reaching this conclusion, the Committee has applied the criteria specified in section 32 . 6.4 The Committee has also applied the following criteria contained in the Methodology: clause 9 – equivalent of sections 5, 6 and 8; clause 11 – characteristics of substances; clause 21 – the decision accords with the requirements of the Act and regulations; clause 22 – the evaluation of risks – relevant considerations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques. 6.5 The application to manufacture in containment the hazardous substance GEDR on 0.15% 1080 Pellets is thus approved pursuant to section 32, with controls as set out in Appendix 1. signed Neil Walter Date 12 September 2007 Chair Environmental Risk Management Authority ERMA New Zealand Approval Code: GEDR on 0.15% 1080 Pellets: HSC000287 ERMA New Zealand Decision: Application HSC07024 Page 9 of 11 Appendix 1: List of controls that apply to the hazardous substance GEDR on 0.15% 1080 Pellets 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 of EPRO Ltd. 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, or 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 GEDR on 0.15% 1080 Pellets HSC07024 HSC000 Noel McCardle 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. ERMA New Zealand Decision: Application HSC07024 Page 10 of 11 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 map provided with the application. 15. A full monitoring report shall be provided to ERMA New Zealand on completion of the trials. 16. This approval remains in place until 31 December 2007. 17. A maximum amount of 18 tonnes of GEDR on 0.15% 1080 Pellets shall be applied to 9000 hectares of treatment area. ERMA New Zealand Decision: Application HSC07024 Page 11 of 11