ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 12 November 2008 Application Code HSC08028 Application Type To import hazardous substances into containment, or manufacture in containment, for export only purposes under Section 31 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Applicant DuPont (New Zealand) Ltd Purpose of the Application To relabel or store Prevathon® Insecticide for export to the Pacific Islands (export only). Date Application Received 3 October 2008 Consideration Date 12 November 2008 Considered by Rob Forlong, Chief Executive of ERMA New Zealand 1 Summary of decision 1.1 The formulating, relabelling, repackaging or storage of Prevathon® Insecticide for export to the Pacific Islands, is approved with controls in accordance with the relevant provisions of 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: Prevathon® Insecticide 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 matters to be considered in that section and additional matters 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 3 October 2008. 3.2 Evaluation of the application was undertaken by the ERMA New Zealand project team which comprised the following staff members: Jo Prankerd Eugene Georgiades Noel McCardle Advisor (Hazardous Substances) Advisor (Hazardous Substances) Senior Advisor (Hazardous Substances). 3.3 The following documents were submitted in support of this application: 3.4 the application; confidential data regarding the formulation; a copy of the Prevathon® Insecticide label. The following Government department was advised of the receipt of the application (in accordance with clause 2(2)(e)) and given the opportunity to comment: the Department of Labour (Workplace Group); 3.5 No responses were received. 3.6 The applicant was provided with a copy of the proposed controls for Prevathon® Insecticide and given the opportunity to comment on them. The applicant had no concerns with the controls. 4 Consideration Sequence of the consideration 4.1 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 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. 4.2 This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e)). Purpose of the application 4.3 This application has been submitted to gain approval to import a fully formulated insecticide product into containment for the purpose of relabelling and storage for subsequent export to the Pacific Islands. 4.4 The project team considers that the purpose of the application qualifies it to be considered under section 30(ca) as the substance will be stored and relabelled for export to a destination outside New Zealand. Lifecycle of the substance 4.5 DuPont (New Zealand) Ltd intends to import Prevathon® Insecticide into New Zealand as a manufactured product. The product will be packed in 100 ml polyethylene bottles, 8 bottles to a cardboard carton. Once imported the substance will be transported, by a specially designated carrier (such as Chemcourier Services), to the DuPont (New Zealand) Ltd warehouse in Manukau City. This is where the product will be relabelled with the label relevant to the Pacific Islands destination. The applicant expects to import and relabel approximately 500 litres of Prevathon® Insecticide annually. 4.6 Prevathon® Insecticide will be stored in the dedicated chemical warehouse of DuPont (New Zealand) Ltd in Manukau City. This store has PRINCE accreditation, location certificate and two approved handlers on site. It is bunded, well equipped with fire extinguishers and carries the approved signage. ERMA New Zealand Decision: Application HSC08028 2 The staff are trained in and are familiar with the procedures for the safe handling, storage and preparation of products for transport. 4.7 The applicant has stated that the substance will not be released for sale or use in New Zealand. 4.8 Once relabelled, the substance will be despatched to the Auckland Airport for transportation to the Pacific Islands again using the designated carrier. The applicant has indicated that the substance will be exported to Fiji, Samoa, Tonga, Tahiti, New Caledonia, Cook Islands, Papua New Guinea and Vanuatu. Hazardous properties of the substance 4.9 Typically containment applications only require sufficient understanding of the hazardous properties of the substance concerned to ensure that any risks can be managed by the containment controls. However, because Prevathon® Insecticide is being exported for use outside New Zealand, the project team considers that that the substance’s hazards should be clearly identified so that they can be communicated and thus aid in the informed assessment of the substance within the importing country. 4.10 The project team has evaluated the classification determined by the applicant for Prevathon® Insecticide in relation to the information supplied and other available data sources; refer Table 4.1. The hazard profile determined by the project team has been based on the read across from formulation data provided by the applicant for application HSR07132, data for individual components and the application of mixture rules where formulation data was not available. The mixture rules applied are as defined in the ERMA New Zealand publication “User guide to HSNO thresholds and classifications”. Table 4.1: Comparison of applicant’s and project team’s hazard classifications Hazard Category Target organ toxicity Aquatic ecotoxicity Applicant Assessment 9.1A Project Team Assessment 6.9B 9.1A 4.11 The project team notes that the applicant has not classified Prevathon® Insecticide as a target organ toxicant (6.9B). 4.12 Based on the information provided and additional information available to it, the project team considers that its classifications are more representative of the substance’s hazardous properties. Thus, these classifications have been used for the purposes of assessing this application and assignment of default controls that would require consideration if the substance were to undergo full assessment and approval in New Zealand. Identification and evaluation of the significant risks of the substance in containment within New Zealand 4.13 The applicant has identified and assessed potential risks and detailed proposals for, and impacts of, risk management. The project team has reviewed the potential risks to the environment, human health and welfare and Maori issues and concerns as set out below. ERMA New Zealand Decision: Application HSC08028 3 4.14 It is noted that a full risk assessment has not been carried out for Prevathon® Insecticide for two main reasons. The first is that the HSNO controls cannot be enforced outside New Zealand, and the second that significant differences in environmental susceptibility and legislative requirements may exist within the importing country. However, it is considered appropriate to review the hazardous nature of the substance to ensure that the detail available to importing nations regarding the substance is as complete as possible. Risks to the environment of the substance in containment 4.15 Given the harmful nature of Prevathon® Insecticide in the aquatic environment, the project team considers that it has the potential to cause adverse effects if it were to come into contact with aquatic organisms. 4.16 Due to the substance’s export-only status it is noted that the lifecycle stages occurring in New Zealand are limited; refer Paragraphs 4.5 to 4.8 above. However, if an incident was to occur during one of those lifecycle stages, for example, during transport to the port or shipping within New Zealand waters, the effects could be severe. However, it is noted that the overall impact would be largely dependant on the volume of the substance released and the susceptibility of the environment and organisms exposed. 4.17 In assessing the risks to the environment while the Prevathon® Insecticide is in New Zealand, the project team noted the specialised nature of the repackaging and storage facilities, the protection provided by the packaging during import, and the containment provisions specified by the applicant and those set under the Act and other relevant legislation. 4.18 Given the factors described above, the project team considers that no significant risks will be posed to the environment. Risks to human health and welfare of the substance in containment 4.19 As Prevathon® Insecticide has been classified as a target organ toxicant, the project team considers that it has the potential to cause harm to human health and welfare if ingested. 4.20 On the basis of the lifecycle of the substance outlined in Paragraphs 4.5 to 4.8 above, adverse health effects could arise from: an incident during handling or repackaging of the substance that results in the substance being ingested, an accident during storage or transportation, resulting in release of the substance and subsequent ingestion, failure to follow the correct operational procedures as set out in the controls, resulting in release and ingestion of the substance. 4.21 In determining the overall level of risk posed to human health while the substance is in New Zealand, the project team has taken into account the specialised nature of the repackaging facilities; the trained, informed and equipped nature of the staff handling the substance, its restricted accessibility, and the additional requirements set under the Act and other relevant legislation. 4.22 Given the factors outlined above, the project team considers it highly improbable that any significant risks will be posed to human health or welfare through the ERMA New Zealand Decision: Application HSC08028 4 contained importation and repackaging of Prevathon® Insecticide in New Zealand for export to Pacific Island Nations. Māori issues and concerns about the substance in containment 4.23 The project team considered the potential Māori cultural effects in accordance with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8. In addition, the project team applied the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the HSNO Act 1996” in consideration of this application. 4.24 As Prevathon® Insecticide is ecotoxic in the aquatic environment, the project team considers that the potential exists for the substance to affect the mauri of taonga flora and fauna, the environment and the general health and well-being of individuals and the community. In addition the potential exists for Prevathon® Insecticide to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways. 4.25 After careful consideration of the risks associated with the contained importation and relabelling of Prevathon® Insecticide for export only purposes, the project team does not consider that any significant adverse effects are likely to occur to Māori culture or traditional relationships with their ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. 4.26 This assessment is made on the condition that the compounds are imported, handled, stored and transported in accordance with the explicitly stated HSNO controls, and any controls stipulated in other applicable Acts. However, should an accident result in the contamination of waterways or the environment, it is suggested that DuPont (New Zealand) Ltd notify the appropriate authorities including the relevant iwi authorities in that region. This action should include advising them of the contamination and the measures taken to contain and remedy it. International considerations of the substance in containment 4.27 Due to the limited scope of the “containment” approval pathway provided for export-only substances and the potential variability in environmental conditions and legislative requirements in importing nations, the project team has not conducted any risk assessment on lifecycle stages that will occur outside of New Zealand. 4.28 In previous decisions, the Authority has considered it appropriate, for exportonly substances approved under the “containment” pathway, to determine the hazard profile for these substances and set out the default controls that would be considered if the substance was to be approved for use in New Zealand. It is noted that this level of assessment is greater than would normally be conducted for containment applications; however, it is considered necessary to meet New Zealand’s obligations to promote informed approval and use of hazardous substances in importing countries. 4.29 The applicant has noted that Prevathon® Insecticide and other formulations based on the same active ingredient are approved around the world including the USA, EU, Australia and New Zealand. The applicant has further noted that the Pacific Islands are signatories are have implemented both FAO International ERMA New Zealand Decision: Application HSC08028 5 Code of Conduct on the Distribution and Use of Pesticides and the Rotterdam Convention on Prior Informed Consent. 4.30 The applicant has indicated they have made an application for an approval with the ACVM Group to import Prevathon® Insecticide for the purposes of export. 4.31 The project team considers that the information provided in this decision, in particular, the hazard classification, should provide regulating bodies within the importing nation(s) with an overview of the substance, which may be used for preliminary screening or as part of an assessment. 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: 5.2 to limit the likelihood of escape of any contained hazardous substances or contamination by hazardous substances (for example, control 4 c); to exclude organisms and unauthorised people from a facility (for example, control 4 b); to control the effects of any accidental release of the substance (for example, control 14); inspection and monitoring requirements (for example, control 6); and qualifications required of the person responsible for implementing the controls (for example, control 12). The project team is satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, Prevathon® Insecticide can be adequately contained within New Zealand. 6 Decision 6.1 Under section 32(1), I may approve this application if the application is for one of the purposes specified in section 30 and if I am satisfied that the substance can be adequately contained. 6.2 Under section 32(2), an approval must include controls that provide for each of the applicable matters specified in the Third Schedule to the Act and that provide for other matters that give effect to the purpose of the Act. 6.3 I have considered the application made by DuPont (New Zealand) Ltd, under section 31, to import and repackage the substance Prevathon® Insecticide in containment for export only purposes. 6.4 I am satisfied that the application is for the purpose of “formulating, re-labelling, repackaging or storing any hazardous substance for export to a destination outside New Zealand” as provided for in section 30(ca). 6.5 I have considered the risks associated with the substance’s lifecycle in New Zealand, as evaluated by the project team. As a result, I am satisfied that the controls proposed under section 32(2), as set out in Appendix 1, and the requirements of other legislation will result in the substance being adequately contained. ERMA New Zealand Decision: Application HSC08028 6 6.6 As well as considering the matters set out in section 32, I have also applied the following criteria in the Methodology in reaching my decision: 6.7 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. As I am satisfied that the requirements of section 32 have been met, I approve the application made by DuPont (New Zealand) Ltd to import and repackage Prevathon® Insecticide in containment for export only purposes. This approval is subject to the controls as set out in Appendix 1. Rob Forlong Date : 12 November 2008 Chief Executive of ERMA New Zealand Substance Identifier ERMA New Zealand Approval Code Prevathon® Insecticide HSC000356 ERMA New Zealand Decision: Application HSC08028 7 APPENDIX 1: List of controls that apply to the hazardous substance, Prevathon® Insecticide Scope 1. 2. This approval covers: a. the contained importation and storage of the substance identified as Prevathon® Insecticide in its original internationally compliant transport packaging. b. the contained repackaging and subsequent contained storage and transport of Prevathon® Insecticide in New Zealand. This approval specifically excludes the use of Prevathon® Insecticide in New Zealand. Note: When quantities of Prevathon® Insecticide are held in New Zealand for purposes outside those stated in this approval, for example analysis of samples, they are not covered under this approval and are only legally permissible if securely held within an exempt laboratory. Repackaging 3. 4. DuPont (New Zealand) Ltd or its nominated agent may repackage quantities of Prevathon® Insecticide into containers that comply with the Hazardous Substances (Packaging) Regulations 2001. The facility used to repackage Prevathon® Insecticide shall: a. be managed to exclude unauthorised persons from accessing the facility; b. be managed to exclude unwanted organisms from the facility; c. provide mechanisms to prevent the unintended release of the substance, for example secondary containment; d. have an emergency management plan in place to deal with spillage events. Notification and inspection 5. 6. 7. If for any reason a breach of containment occurs in New Zealand, DuPont (New Zealand) Ltd shall, within 24 hours of the breach being detected: a. notify Department of Labour and ERMA New Zealand; b. inform the relevant iwi authority, if the breach in containment results in contamination of any waterbody. The Authority or its authorised agent or properly authorised enforcement officers, may inspect the manufacture and storage facilities at any reasonable time. Documentation regarding the substance’s lifecycle, notwithstanding its confidential nature, shall be available for inspection by any authorised enforcement officer, upon request. The hazard profile, as determined by ERMA New Zealand, shall be supplied to the body registering or assessing Prevathon® Insecticide within the importing nation. The importing or registering body shall also be made aware of the ERMA New Zealand Decision: Application HSC08028 8 availability of this decision document and of the controls that would be considered if it were to be used in New Zealand. Storage 8. Prevathon® Insecticide shall be securely stored in accordance with good practice within secure facilities. This may be demonstrated by compliance with the Code of Practice for the Management of Agrichemicals NZS 8409: 2004. Transport 9. Prevathon® Insecticide shall be transported in accordance with good practice and where appropriate in compliance with the relevant requirements of the Land Transport Act 1998, the Civil Aviation Act 1990 or the Maritime Transport Act 1994. Labelling 10. Packages containing Prevathon® Insecticide shall be labelled in accordance with the Hazardous Substances (Identification) Regulations 2001 or in accordance with the alternative labelling requirements as set out below and in control I19 of Appendix 2. Alternative labelling requirements for export-only substances Individual packages 1) The packaging of single containers of Prevathon® Insecticide, whether contained within a multiple package or not, may comply with the labelling requirements of a) the Food and Agricultural Organisation of the United Nations (FAO), Guidelines on Good Labelling Practice for Pesticides, 1995, or b) the Globally Harmonised System; or c) a relevant regulatory authority as recognised by ERMA New Zealand in the country of destination. i) for Prevathon® Insecticide the labelling that meets the requirements of the Australian Pesticides and Veterinary Medicines Authority (APVMA) is recognised by ERMA New Zealand. ii) for Prevathon® Insecticide the labelling that meets the Fijian approval as granted under the Fiji Pesticides Act No. 41 of 1971 (Fiji), Registered No. W131/110F/76 2) If individual packages comply with (1), they need not comply with – a) regulations 11 and 12 of the Hazardous Substances (Disposal) Regulations 2001; and b) regulations 6 to 8 of the Hazardous Substances (Emergency Management) Regulations 2001; and c) regulations 6, 7, 9, 18, 20, or 25 of the Hazardous Substances (Identification) Regulations 2001. ERMA New Zealand Decision: Application HSC08028 9 Multiple packaging 1) These requirements apply to Prevathon® Insecticide when in multiple packaging. 2) The outer packaging of a multiple package must bear: a) the priority identifier information required by regulations 9 and 14 of the Hazardous Substances (Identification) Regulations 2001; or b) the labelling or marking required by i) Land Transport Rule 45001: Dangerous Goods 2005; or ii) Civil Aviation Rule 92: Carriage of Dangerous Goods; or iii) Maritime Rule 24A: Carriage of Cargoes - Dangerous Goods; or c) the pictogram for “Dangerous in the Environment” as described in directive 92/32/EEC (instead of identifier requirements of regulations 9 and 20); or d) the relevant class or subclass label assigned by the UN Model Regulations. 3) The outer packaging of a multiple package must be identified with enough information to enable its New Zealand supplier or manufacturer to be contacted, either in person or by telephone. 4) The outer packaging of a multiple package to shall not have on its packaging, or with it, any information suggesting that it belongs to a class or subclass it does not in fact belong to. 5) The outer packaging of a multiple package which complies with (2) to (4) need not comply with regulations 18, 19, 20, 25 and 30 of the Hazardous Substances (Identification) Regulations 2001. 6) Any requirement to label the outer packaging of a multiple package as containing a substance that is hazardous to the environment/ecotoxic, as specified in subclauses (2) to (4), is omitted when the substance is stored in New Zealand in a secure warehouse or other secure storage facility owned, operated or otherwise under the control of the manufacturer or the shipping agent prior to exportation from New Zealand. Safety Data Sheets 11. A Safety Data Sheet (SDS), compliant with the Hazardous Substances (Identification) Regulations 2001 shall be present with the substance at all stages of the lifecycle of Prevathon® Insecticide in New Zealand. The SDS shall be available within 10 minutes. Handling of the substance 12. Persons handling Prevathon® Insecticide during the repackaging processes shall have received training in the safe handling and management of hazardous chemicals or be under the supervision of persons with this knowledge. ERMA New Zealand Decision: Application HSC08028 10 13. Appropriate personal protective equipment (PPE), for example, safety glasses, gloves and protective clothing shall be worn by persons handling the substance during repackaging and disposal; refer Appendix 2. Emergency management 14. Any party handling Prevathon® Insecticide shall comply with the emergency management provisions as prescribed by regulations 25 to 42 of the Hazardous Substances (Emergency Management) Regulations 2001(refer controls EM11, EM12 and EM13, Appendix 2). Disposal 15. 16. If Prevathon® Insecticide requires disposal in New Zealand, it shall disposed of in a manner compliant with the requirements of the Hazardous Substances (Disposal) Regulations 2001. Any rinsate, washings, or residue generated during the repackaging of Prevathon® Insecticide shall be treated or disposed of in a manner compliant with Hazardous Substances (Disposal) Regulations 2001, for the hazards posed. ERMA New Zealand Decision: Application HSC08028 11 APPENDIX 2: Reference HSNO controls for Prevathon® Insecticide Note: The controls listed in this appendix are for reference only purposes. The controls set for Prevathon® Insecticide are as defined in Appendix 1. The controls listed in this appendix are defaults that have been triggered solely based on the hazards posed by the substance. After the risks associated with the substance’s lifecycle have been assessed these controls may be modified or deleted to suit the particular risks profile. These controls may also be supplemented by additional controls where risks have been identified that would not otherwise be mitigated by the default controls listed. The regulations are available at http://www.legislation.govt.nz Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T1 11-27 Limiting exposure to toxic substances through the setting of TELs T2 29, 30 Controlling exposure in places of work through the setting of WESs T4 7 Requirements for equipment used to handle hazardous substances T5 8 Requirements for protective clothing and equipment Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 Limiting exposure to ecotoxic substances through the setting of EELs E2 46-48 Restrictions on use of substances in application areas E5 5(2), 6 Requirements for keeping records of use E6 7 Requirements for equipment used to handle substances E7 9 Approved handler/security requirements for certain ecotoxic substances Hazardous Substances (Identification) Regulations 2001 I1 6, 7, 32-35, 36 Identification requirements, duties of persons in charge, (1)-(7) accessibility, comprehensibility, clarity and durability I3 9 Priority identifiers for ecotoxic substances I9 18 Secondary identifiers for all hazardous substances I11 20 Secondary identifiers for ecotoxic substances I16 25 Secondary identifiers for toxic substances I17 26 Use of generic names I18 27 Requirements for using concentration ranges I19 29-31 Additional information requirements, including situations where substances are in multiple packaging I21 37-39, 47-50 General documentation requirements I23 41 Specific documentation requirements for ecotoxic substances I28 46 Specific documentation requirements for toxic substances I29 51-52 Signage requirements 1 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. 3 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. ERMA New Zealand Decision: Application HSC08028 12 Control Code1 Regulation2 Explanation3 Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7(1), 8 General packaging requirements P3 9 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria P15 21 Packaging requirements for ecotoxic substances PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group III PS4 Schedule 4 Packaging requirements as specified in Schedule 4 Hazardous Substances (Disposal) Regulations 2001 D4 8 Disposal requirements for toxic and corrosive substances D5 9 Disposal requirements for ecotoxic substances D6 10 Disposal requirements for packages D7 11, 12 Information requirements for manufacturers, importers and suppliers, and persons in charge D8 13, 14 Documentation requirements for manufacturers, importers and suppliers, and persons in charge Hazardous Substances (Emergency Management) Regulations 2001 EM1 6, 7, 9-11 Level 1 information requirements for suppliers and persons in charge EM7 8(f) Information requirements for ecotoxic substances EM8 12-16, 18-20 Level 2 information requirements for suppliers and persons in charge EM11 25-34 Level 3 emergency management requirements: duties of person in charge, emergency response plans EM12 35-41 Level 3 emergency management requirements: secondary containment EM13 42 Level 3 emergency management requirements: signage Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable applicable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notices NonSchedule 8, The controls relating to stationary container systems, as set out in flammable DGTN March Schedule 8 of the Hazardous Substances (Dangerous Goods and liquids 2004 Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, shall apply to this substance, notwithstanding clause 1(1) of that schedule. AH1 4-6 Approved handler requirements TR1 4(1), 5, 6 General tracking requirements ERMA New Zealand Decision: Application HSC08028 13