ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 24 June 2005 Application Code HSC05011 Application Type To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous Substances and New Organisms (HSNO) Act 1996 Tomen New Zealand Limited Level 16 120 Albert Street Auckland Applicant Purpose of the Application To import a small quantity of amicarbazone for evaluation for weed control in forestry Date Application Received 1 June 2005 Consideration Date 24 June 2005 Considered by Bas Walker, Chief Executive of ERMA New Zealand 1 Summary of Decision 1.1 The application to import into containment the hazardous substance Amicarbazone is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO 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: Amicarbazone 2 Legislative Criteria for Application 2.1 The application was lodged pursuant to section 31 of the HSNO Act. 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 HSNO Act and the provisions of Part III of the Third Schedule of the HSNO Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the HSNO Act. ERMA New Zealand Decision: Application HSC05011 Page 1 of 9 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 1 June 2005 and assessed as having sufficient information on 2 June 2005. 3.2 Project Team: Beth Dye Applications Manager (Hazardous Substances) Sue Scobie Senior Adviser (Hazardous Substances) Zack Bishara Advisor, Māori Unit Report review and sign-out by: Noel McCardle Team Leader, Applications (Hazardous Substances) 3.3 The applicant supplied the following documents: The application, including confidential appendices. 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 (Occupational Safety and Health) 3.5 A response was received from the Ministry of Health, stating that “with appropriate HSNO controls, the Ministry has no issues to raise at this time relating to the acceptance of this application based on non-confidential information provided from a public health perspective (non-occupational).” 3.6 The applicant was provided with a copy of the proposed controls for Amicarbazone and given the opportunity to comment on them. The applicant replied that they had no comments to make on the proposed controls. 4 Consideration Sequence of the Consideration 4.1 This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e) of the HSNO Act). 4.2 In accordance with section 32 of the Act, 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 ERMA New Zealand Decision: Application HSC05011 Page 2 of 9 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 The purpose of the application is to import a small quantity of amicarbazone for evaluation for weed control in forestry. 4.4 As the purpose amounts to “research and development on any hazardous substance”, I consider that the application qualifies for consideration under section 30(ba) of the Act. Life Cycle 4.5 The applicant has provided the following details of the lifecycle. 4.6 Approximately 400g of the substance will be imported. The substance will be kept in designated laboratories. Dilutions will be prepared in a building (close to the trial site) designed to contain any spills that may occur. Spray mix solutions will be taken to the trial site and applied by hand held sprayer. After application, all spray equipment will be returned to the building and triple rinsed to remove any residual spray solution. Waste will be collected in contained waste water tanks which are disposed of by an approved contractor. Hazardous Properties 4.7 I note that a containment application requires only sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls. 4.8 The applicant has examined the properties of the components, and considers that the substance will trigger thresholds for acute oral toxicity and aquatic ecotoxicity. I note that the Material Safety Data Sheet supplied with the application also indicates possible mild eye irritation and target organ toxicity. 4.9 I have reviewed the applicant’s hazard information and I consider that the information is sufficient for me to determine that any risks can be managed by the containment controls. Identification and Evaluation of the Significant Risks of the Substance in Containment 4.10 In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential risks of escape from containment under the headings of environmental, human health and welfare and Māori issues and concerns. 4.11 In the application, the applicant identified and assessed potential risks, and detailed proposals for and impacts of risk management. I have reviewed the applicant’s assessment of the risks and agree that it is suitable for the consideration below. ERMA New Zealand Decision: Application HSC05011 Page 3 of 9 Risks to the Environment 4.12 If released off target, the substance has the potential to cause adverse effects on aquatic organisms. 4.13 On the basis of the lifecycle of the substance outlined in paragraph 4.6, adverse effects could arise from: An accident during storage, use or transportation, resulting in release of the substance Failure to follow correct disposal procedures. 4.14 I consider that, taking into account the properties of the substance, the quantity involved, the containment regime proposed by the applicant, the containment controls in Appendix 1 and controls in place under other legislation, there are no significant risks to the environment. Risks to Human Health and Welfare 4.15 If the substance is ingested or contacts eyes, there is the potential to cause adverse effects on human health. 4.16 On the basis of the lifecycle of the substance outlined in paragraph 4.6, adverse effects could arise from: An accident during storage, use or transportation, resulting in release of the substance Failure to follow correct disposal procedures. 4.17 I consider that, taking into account the properties of the substance, the quantity involved, the containment regime proposed by the applicant, the containment controls in Appendix 1 and controls in place under other legislation, there are no significant risks to human health and welfare. Māori issues and concerns 4.18 I have considered the potential Māori cultural effects of this application in accordance with sections 6(d) and 8 of the HSNO Act, and the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the HSNO Act 1996”. 4.19 I note that the quantity, trial site location and application procedures outlined by the applicant have been designed to mitigate and manage any potential risks to people, communities and the environment 4.20 From the information provided, and considering that the application is for a containment trial involving low volumes of the substance, I consider that it 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. ERMA New Zealand Decision: Application HSC05011 Page 4 of 9 4.21 However, should inappropriate or accidental use, transport or disposal of the substance result in the contamination of waterways, it is suggested that the applicant notify the appropriate authorities including the relevant 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 I have 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 (for example, control 10) To exclude organisms from a facility (for example, control 7) To exclude unauthorized people from the facility (for example, control 6) To prevent unintended release of the substances by experimenters working with the substance (for example, control 9) To control the effects of any accidental release of the substance (for example, control 17) Inspection and monitoring requirements (for example, control 22) Qualifications required of the person responsible for implementing the controls (for example, control 13). 5.2 I am satisfied that with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, Amicarbazone can be adequately contained. 6 Decision 6.1 I have considered this application under section 31 to import into containment a hazardous substance, and pursuant to section 32, I am satisfied that this application is for the purpose specified in section 30(ba). 6.2 Having considered the risks associated with the lifecycle of Amicarbazone, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substance being adequately contained. 6.3 In accordance with clause 36(2)(b) of the Methodology I record that, in reaching this conclusion, I have applied the criteria specified in section 32 of the Act. 6.4 I have also applied the following criteria 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. ERMA New Zealand Decision: Application HSC05011 Page 5 of 9 6.5 The application to import into containment the hazardous substance Amicarbazone is thus approved pursuant to section 32 of the Act, with controls as set out in Appendix 1. Bas Walker Date 24 June 2005 Chief Executive of ERMA New Zealand ERMA New Zealand Approval Code: Amicarbazone: HSC000157 ERMA New Zealand Decision: Application HSC05011 Page 6 of 9 Appendix 1: List of controls that apply to the hazardous substance Amicarbazone 1. The trials shall be undertaken in accordance with the details provided in section 4 of the application. Modifications of these details may be approved in writing by ERMA New Zealand providing that they comply with the following controls. 2. Notwithstanding the requirements of control 1 above, the trials shall also comply with the following controls: 3. The trials shall be carried out at the trial site in the grounds of the New Zealand Forest Research Institute, Rotorua, as identified in the application. 4. The trial sites shall be chosen so as to prevent the substance entering any surface water or groundwater system. 5. The trial sites shall be located to prevent any building where people live or work being exposed to the substance. 6. Access to the trial sites shall be by permission of the Trial Director1 or owner of the property on which it is located. The trial site boundaries shall be clearly marked and distinctly visible from outside the trial site throughout the life of the trials. The trial sites shall be signed indicating that unauthorized access is not allowed, that the site is subject to a trial, and that the crops should not be removed or disturbed. 7. In any location where it is possible for grazing animals to access the trial site, the trial sites shall be secured by stock proof fencing to exclude grazing animals for the duration of the trial. 8. The substance shall be stored in accordance with the Code of Practice for the Management of Agrichemicals NZS8409:2004. 9. The substance shall be mixed, diluted and prepared in any other way prior to application in accordance with the relevant sections of the Code of Practice for the Management of Agrichemicals NZS8409:2004. 10. The substance shall be securely packed in suitable containers that comply with the Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in accordance with the Hazardous Substances (Identification) Regulations 2001. A Safety Data Sheet shall accompany each shipment. 11. The substance shall be transported in compliance with any relevant requirements of the Land Transport Rule: Dangerous Goods 1999. 1 The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the trial in accordance with the Management Plan and approval controls. ERMA New Zealand Decision: Application HSC05011 Page 7 of 9 12. The substance shall be applied by way of hand-held/operator-worn equipment, using hydraulic pressure or compressed CO2 or air on plots specifically designated and marked for each treatment, in accordance with the Code of Practice for the Management of Agrichemicals NZS8409:2004. Special attention shall be paid to the minimisation of spray drift, and in particular to the avoidance of drift beyond boundaries agreed with the owner of the trial site. 13. The personnel applying the substance to the crops shall be able to demonstrate that they have the qualifications necessary to carry out the trial. Ways of demonstrating this would include the holding of appropriate Growsafe certification or an Approved Handler qualification. 14. The amount of spray prepared shall be adequate for the trial site, but if there is any surplus spray mix it shall be disposed of within the trial site by being further diluted and sprayed over a marked and designated non-crop and non-grazed area at the site. 15. Any equipment used shall be rinsed after use with the appropriate detergent or decontaminant, and rinsate disposed of into the designated containment tanks. The waste water contents of these tanks shall be subsequently disposed of by an approved contractor. 16. Surplus substance remaining at the end of the trials shall be returned to Tomen (NZ) Ltd for secure storage in an exempt laboratory, exported or degraded to non-hazardous substances (note that once the trials are complete the substances do not have approval to be present in New Zealand except in an exempt laboratory). 17. Any accidental spillage of the unmixed substance or spray mix shall be contained, prevented from entering waterways, and absorbed with an appropriate absorbent material. This material shall be placed into sealed containers and disposed of at an appropriate waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance policy. 18. A record shall be kept of all use of the substance. This record shall cover all matters referred to in Regulation 6 of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001. 19. Information on appropriate safety precautions necessary to provide safeguards against the substance’s toxic and ecotoxic properties shall accompany the substance at all stages of its lifecycle. Personal protective equipment shall be worn when handling the substance throughout the lifecycle. 20. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or equivalent position] and ERMA New Zealand shall be informed in writing (by letter, fax or email) of the location, start, and completion of the trials. Notifications shall include the following details: Substance name ERMA Application number ERMA Approval number ERMA Applications Advisor ERMA New Zealand Decision: Application HSC05011 Amicarbazone HSC05011 HSC000157 Beth Dye Page 8 of 9 21. If for any reason a breach of containment occurs, the Trial Director shall notify OSH 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. 22. The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. 23. This approval remains in place for a maximum of five years. 24. The maximum total quantity of the substance that shall be imported or manufactured under this approval is 1 kg. ERMA New Zealand Decision: Application HSC05011 Page 9 of 9