ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 25 March 2005 Application Code HSC05004 Application Type To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous Substances and New Organisms (HSNO) Act 1996 Coates New Zealand Ltd 313 Church Street Penrose Auckland To field test the substance Thermal 980 Negative Developer on preproduction of the KodakPolychrome Thermal News printing plates to determine how it performs compared to current products Applicant Purpose of the Application Date Application Received 18 February 2005 Consideration Date 25 March 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 Thermal 980 Negative Developer 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. 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: Thermal 980 Negative Developer 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 HSC05004 Page 1 of 8 2.2 Consideration of the application followed the relevant provisions of the Hazardous Substances and New Organisms (Methodology) Order 1998 (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 18 February 2005 and assessed as having sufficient information on 28 February 2005. 3.2 Project Team: Emma Doust Applications Advisor (Hazardous Substances) Julia Fediaeva Science Adviser (Hazardous Substances) Zack Bishara Advisor, Māori Unit Report review and sign-out by: Beth Dye 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 No responses were received. 3.6 The applicant was provided with a copy of the proposed controls for Thermal 980 Negative Developer 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 HSC05004 Page 2 of 8 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 field test the substance Thermal 980 Negative Developer on preproduction of the KodakPolychrome Thermal News printing plates to determine how it performs compared to current products. 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. 4.6 300 litres will be transported from Europe in 20 litre plastic drums suitable for transport. The substance will then be transferred by a certified shipping company to the Coates New Zealand warehouse. 4.7 The substance will be transferred by a certified road transport company to the newspaper publisher, where it will be placed in sealed catchment devices or a sealed area. 4.8 The fresh developer will replace the spent developer via displacement and will be captured in a large tray or drum. At completion of the trial, a professional water management company will be commissioned to dispose of the substance and to decontaminate the drums used in the trial before they are sent out for recycling. Hazardous Properties 4.9 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. 4.10 The applicant states that there is limited data available on the substance. The applicant has examined the properties of the components, and considers that the substance will trigger thresholds for flammability, acute oral and dermal toxicity, skin and eye irritation. In review of this information I have determined that the flashpoint given is too high to trigger a flammability hazard. I also consider that there is no information available to suggest any ecotoxic hazards. 4.11 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 ERMA New Zealand Decision: Application HSC05004 Page 3 of 8 4.12 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. 4.13 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. Risks to the Environment 4.14 In review of the information, I consider that there is a lack of information suggesting any ecotoxic hazards; therefore this product is unlikely to pose a danger to the environment. 4.15 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 4.16 If the substance is ingested, or contacts skin or eyes, there is the potential to cause adverse effects on human health. 4.17 On the basis of the lifecycle of the substance outlined in paragraph 4.5 – 4.8, adverse effects could arise from: An accident during storage, use or transportation, resulting in release of the substance Failure to follow correct disposal procedures as outlined in the Management Plan. 4.18 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 4.19 I have considered the potential Māori cultural effects of this application in accordance with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the HSNO Act 1996”. 4.20 On the basis of the information provided by the ERMA New Zealand Advisor (Māori), I consider that the substance is unlikely to have an impact on the relationship of Māori and their culture and 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 controls in Appendix 1, and in accordance with any other relevant controls applied under other legislation. ERMA New Zealand Decision: Application HSC05004 Page 4 of 8 4.21 In addition, the trial of this substance does not involve significant community exposure or significant exposure to the environment, so I consider that there is no requirement for the applicant to consult with Māori regarding this application. 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 8) To exclude organisms from a facility (for example, control 4) To exclude unauthorized people from the facility (for example, control 5) To prevent unintended release of the substances by experimenters working with the substance (for example, control 11) To control the effects of any accidental release of the substance (for example, control 11) Inspection and monitoring requirements (for example, control 4) Qualifications required of the person responsible for implementing the controls (for example, control 9) 5.2 I am satisfied that with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, Thermal 980 Negative Developer 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 Thermal 980 Negative Developer, 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 HSC05004 Page 5 of 8 6.5 The application to import into containment the hazardous substance Thermal 980 Negative Developer is thus approved pursuant to section 32 of the Act, with controls as set out in Appendix 1. Bas Walker Date 25 March 2005 Chief Executive of ERMA New Zealand ERMA New Zealand Approval Code: Thermal 980 Negative Developer: HSC000151 ERMA New Zealand Decision: Application HSC05004 Page 6 of 8 Appendix 1: List of controls that apply to the hazardous substance Thermal 980 Negative Developer 1. The trials shall be undertaken in accordance with the Management Plan, which accompanied the application. Modifications of the Management Plan 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 trial shall be restricted to the site of Guardian Print, Kermode Street, Ashburton. 4. The trial site shall be a secure site. Inspection and monitoring of the trial site will be carried out by operators on the site and in accordance with the site’s own standard operating procedure. 5. Access to the trial site shall be restricted to entry by approved personnel only. 6. 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 the shipment. 7. The substance shall be transported in compliance with any relevant requirements of the Land Transport Rule: Dangerous Goods 1999. 8. The substance shall be stored only at Coates warehouse and the trial site. The substance shall be stored in a bunded area. 9. The personnel involved in the trial shall be able to demonstrate that they have the qualifications necessary to carry out the trial work. Ways of demonstrating this would include being able to provide upon request, evidence of training in the use of equipment to be used in the trial or the holding of an Approved Handler qualification. 10. Surplus substance remaining at the end of the trials shall be returned to Coates New Zealand Ltd for secure storage in an exempt laboratory, exported or degraded to nonhazardous 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). 11. Any accidental spillage of the substance 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. 12. A record shall be kept of all use of the substance. 13. The used substance shall be disposed of by a certified waste management company only. ERMA New Zealand Decision: Application HSC05004 Page 7 of 8 14. Thermal 980 Negative Developer shall not be offered for sale. 15. 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 (PPE) shall be worn when handling the substance throughout the lifecycle. 16. 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 Thermal 980 Negative Developer HSC05004 HSC000151 Emma Doust 17. 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. 18. The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. 19. This approval remains in place for 1 year. 20. The maximum total quantity of the substance that shall be imported or manufactured under this approval is three hundred litres. 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