ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 03 September 2008 Application Code HSC08013 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”) Sumika Enviro-Science Co. Ltd. Applicant Purpose of the Application To import or manufacture into containment Everwood DF, containing dinotefuran insecticide, for use with an in-line glue treatment in radiata pine plywood manufacture to enable evaluation of the level of insect damage prevention under Japanese conditions. Date Application Received 22 July 2008 Consideration Date 02 September 2008 Considered by Rob Forlong, Chief Executive of ERMA New Zealand 1 Summary of Decision 1.1 The application to manufacture in containment the hazardous substance, Everwood DF, 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: Everwood DF 2 Purpose of the Application 2.1 3 The applicant states the purpose of the research and development is to evaluate the efficacy of Everwood DF as a glue-line treatment for protecting radiata pine plywood from insect attack, particularly from subterranean termites. The treated plywood will be exported to Japan for critical evaluation under varied but controlled trial conditions for potential commercial use in that country. Application process 3.1 The application was formally received on 22 July 2008. 3.2 3.3 3.4 Project Team: Matthew Allen Advisor (Hazardous Substances) Sekove Tinalevu Advisor (Hazardous Substances) Zack Bishara Advisor, Māori Unit Noel McCardle Senior Advisor (Hazardous Substances). The applicant supplied the following documents: the application; and a confidential appendix, containing information regarding: chemical formulation; trial project plan; description of Juken New Zealand Ltd, and Gisborne Mill procedures, facilities and management. The following government department was advised of the receipt of the application and given the opportunity to comment: o 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 Everwood DF and given the opportunity to comment on them. The applicant had no concerns with the controls. 4 Consideration Eligibility 4.1 As the purpose (see section 2.1) 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 The applicant advises that the substance will be dealt with throughout its lifecycle in the following way: Importation, transport and storage of Everwood DF 4.2.1 Everwood DF is manufactured, packed and labelled in Japan. It is shipped to NZ in sealed, ready to use containers for storage at the appropriate facilities of the end-user. The pack size proposed is 25 litres in HDPE packaging construction. ERMA New Zealand Decision: Application HSC08013 Page 2 of 12 4.2.2 Appropriate storage and segregation during transport between various locations is required. The maximum amount required for trial treatments to enable adequate evaluation of different concentration rates over a period of time is 150 L. Use of Everwood DF 4.2.3 Everwood DF is incorporated into a glue line treatment as a wood preservative to prevent damage from various insect pests in radiata pine plywood. 4.2.4 The application of Everwood DF in the manufacture of plywood is via a closed automated system. 4.2.5 Everwood DF is incorporated into and applied by an automated glue line applicator. Everwood DF is pre-mixed with the appropriate plywood adhesive and can be applied by roller coaters, curtain coaters, spray coaters or liquid foam extruders. The methodology depends on the physical characteristics and properties of the mixture. The proposed application rate is 1 kg (Everwood DF) / m3. 4.2.6 Evaluation of different concentrations of Everwood DF in the adhesive will be trialled, such that the application rate is modified slightly from the proposed rate. 4.2.7 Juken New Zealand Ltd., at its Gisborne Mill site, is the only timber company that will carry out the trials using Everwood DF. The Trial Director will be the Assistant Mill Manager, who is responsible for such applications. Any employee of Juken New Zealand Ltd. will be under the supervision of the Assistant Mill Manager. 4.2.8 All of the treated plywood will be exported to Japan for evaluation against wood boring insects such as termites etc., with the exception of a small amount of treated plywood that will be stored in New Zealand for reference and analytical purposes. 4.2.9 None of the Everwood DF-treated plywood would be distributed to the public or available for commercial sale or use within New Zealand. Exportation of Everwood DF-treated plywood 4.2.10 With the exception of a small representative selection of retention samples (for reference and analysis) to be kept in secure storage at the timber treatment facility, all treated timber (whether trial samples or scrap) is wrapped, sealed and palletised for export to Japan for biological testing and eventual disposal. Disposal of Everwood DF 4.2.11 Any product remaining in disposable applicators is not returned to the original container. The empty labelled container is crushed and buried in a landfill. All disposal will be in a manner compliant with the requirements of the Hazardous Substances (Disposal) Regulations 2001. ERMA New Zealand Decision: Application HSC08013 Page 3 of 12 4.2.12 Any surplus Everwood DF to be disposed of must not be emptied into an enclosed drain to avoid the potential of water contamination. 4.2.13 Unused Everwood DF will be securely stored for future trials, until release approval for commercial use has been given, or returned to the overseas supplier. All disposal will be in a manner compliant with the requirements of the Hazardous Substances (Disposal) Regulations 2001. 4.2.14 Following gluing, cold and hot pressing takes place before trimming, sanding and packaging. During these operations, all waste is collected for export to Japan, or appropriate disposal in a manner compliant with the requirements of the Hazardous Substances (Disposal) Regulations 2001. Hazardous properties 4.3 The Agency has examined the hazardous nature of Everwood DF and considers that the following hazard classifications are triggered: o Eye irritancy (6.4A) o Reproductive/developmental toxicity (6.8B) o Target organ systemic toxicity (6.9B) o Aquatic ecotoxicity (9.1B) o Terrestrial invertebrate ecotoxicity (9.4A). 4.4 The Project Team has reviewed the summary data and other information supplied by the applicant and considers that the information 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 containment controls. Identification and evaluation of the significant risks of the substance in containment 4.5 The applicant has identified and assessed potential risks and detailed proposals for, and impacts of, risk management. The Project Team has reviewed the applicant’s assessment of the risks to the environment, human health and welfare and Māori issues and concerns as set out below. The applicant has given specific consideration to the following: o Everwood DF will be handled in a contained environment (timber treatment facility); o Everwood DF will be under the control of an approved handler during use; o the operators are familiar with the sort of risks posed by adhesive mixtures and treatment chemicals, trained and experienced in the handling of substances of this nature; o the timber treatment facility is a secure commercial establishment, that does not permit unauthorised access by the public; ERMA New Zealand Decision: Application HSC08013 Page 4 of 12 o glue formulations are generally hazardous and it is unlikely that the inclusion of Everwood DF in the glue line treatment would significantly alter the risks associated with the handling or exposure to the treated sawdust from trimming and sanding the treated plywood before packaging; o Everwood DF-treated plywood will not be available for sale in New Zealand, and, therefore, the likelihood of exposure to treated plywood to the New Zealand public is considered extremely low. Risks to the environment 4.6 The Project Team considers that adverse effects to the environment may result from exposure to Everwood DF, given that Everwood DF is ecotoxic to the aquatic environment, and to terrestrial invertebrates. 4.7 Everwood DF is highly ecotoxic to the environment. If released into the environment the substance has the potential to result in adverse effects on nontarget species. 4.8 On the basis of the lifecycle of the substance adverse environmental effects could arise from: o an accident during storage, use or transportation, resulting in release of Everwood DF or Everwood DF-treated plywood; o failure to follow the correct operational procedures as set out in the controls and containment system as described in the application, resulting in release of Everwood DF or Everwood DF-treated plywood; or o failure to follow correct disposal procedures. 4.9 The Project Team has considered the ecotoxic properties of Everwood DF, the quantities required for the trials (150 L), the nature of the manufactured plywood and adequate packaging, the containment systems in place at the timber treatment site, the controls listed in Appendix 1 of this decision and requirements under other legislation. Based on these considerations, the Project Team considers that risks to the environment from this trial can be adequately managed. Risks to human health and welfare 4.10 The Project Team considers that adverse effects to human health and welfare may result from exposure to Everwood DF, given that the substance has toxic properties and is suspected of being a human reproductive or developmental toxicant. 4.11 On the basis of the lifecycle of the substance adverse effects could arise from: o an accident during storage, use or transportation, resulting in release of Everwood DF or Everwood DF-treated plywood; o failure to follow the correct operational procedures as set out in the controls and the containment system, resulting in personnel exposure while contained; or ERMA New Zealand Decision: Application HSC08013 Page 5 of 12 o failure to follow correct disposal procedures. 4.12 The Project Team has considered the toxic properties of the substance, the quantities required for the trials (150 L), the nature of the manufactured plywood, the containment regime proposed by the applicant, the controls in Appendix 1of this decision and requirements under other legislation. 4.13 Provisions to avoid risk to human health include use of personal protective equipment, adequate packaging of the manufactured plywood and information requirements. Based on these considerations, the Project Team considers that risks to human health and welfare can be adequately managed. Māori issues and concerns 4.14 The Project Team considered this application using the framework contained in the ERMA New Zealand user guide “Working with Māori under the HSNO Act 1996”. 4.15 The applicant and the Project Team noted that Everwood DF triggers HSNO thresholds for toxicity and ecotoxicity may therefore have adverse effects on the relationship of Māori to the environment, particularly with regard to the mauri of native and/or valued species and ecosystems. 4.16 The Project Team notes that the trial facility is a well established timber treatment mill, with suitable provisions to ensure containment of Everwood DF or Everwood DF-treated plywood. 4.17 Taking into account the containment measures proposed, the Project Team considers any likely impact of the substance on the relationship of Māori to their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga to be negligible. In addition, because of the nature of the proposed trial, there is no evidence to suggest that the controlled use of this substance will breach the principles of the Treaty of Waitangi or inhibit the ability of iwi/ Māori to fulfil their role as kaitiaki. Consequently, there is no requirement for the applicant to consult with Maori regarding this application. This assessment is made on the condition that the Everwood-DF-containing substances are handled, stored, transported, used and disposed of, in accordance with the controls. 4.18 However, should inappropriate or accidental use, transport or disposal of the substance result in the contamination of waterways, it is suggested that the Study Director notifies 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. Identification and evaluation of the significant benefits of the substance in containment 4.19 The applicant claims that the proposed trial may lead to the incorporation of a new insecticide substance as a glue line treatment for radiata pine, for use in commercial building applications in Japan. An effective treatment would increase the economic benefits of treating New Zealand plywood veneers for export to Japan. ERMA New Zealand Decision: Application HSC08013 Page 6 of 12 4.20 The Project Team considers that these benefits are significant and that, accordingly, any minor residual risks to people, the environment and to Māori are acceptable. 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: o to limit the likelihood of escape of any contained hazardous substance or contamination by hazardous substances; o to exclude organisms from a facility; o to exclude unauthorised people from the facility; o to prevent unintended release of the substance by experimenters working with the substance; o to control the effects of any accidental release of the substance; o inspection and monitoring requirements; and o 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 and those controls in place under other legislation, Everwood DF can be adequately contained. ERMA New Zealand Decision: Application HSC08013 Page 7 of 12 6 Decision 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 Everwood DF, 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 substance Everwood DF is thus approved with controls as set out in Appendix 1 and in accordance with the relevant provisions of the Act and the Methodology as more specifically set out in Appendix 2. Rob Forlong Date: 03 September 2008 Chief Executive of ERMA New Zealand ERMA New Zealand Approval Code: Everwood DF ERMA New Zealand Decision: Application HSC08013 HSC000337 Page 8 of 12 APPENDIX 1: LIST OF CONTROLS THAT APPLY TO EVERWOOD DF General 1. The trials shall be undertaken in accordance the information specified within sections 3.4, 3.5 and 4 of the application addressing matters to be considered under Part III of Schedule 3 of the Act. Modifications of these specifications may be approved in writing by ERMA New Zealand providing that they comply with the following controls. 2. This approval remains in place for a maximum period of 3 years from the date of this decision. 3. Notwithstanding the requirements of control 1 above, the trials shall also comply with the following controls: Packaging and Information 4. Everwood DF 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. Trial Site 5. The trials shall be carried out at Juken New Zealand’s Gisborne Mill. 6. The trial site shall be chosen so as to prevent the substance entering any surface water or groundwater system. 7. The trial site shall be located to prevent any residential building or workplace which is not related to the research from being exposed to the substance. 8. Access to the trial site shall be by permission of the Trial Director1, or owner or manager of the Gisborne Mill. Storage 9. While not in use, the substances shall be securely stored. This provision shall apply for the duration of the approval. Transport 10. The substances shall be transported in compliance with any relevant requirements of the Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 and the Maritime Transport Act 1994. 1 The Trial Director is the individual appointed by the applicant, and named in the Project Plan as being responsible for the overall conduct of the trial in accordance with the Management Plan and approval controls. ERMA New Zealand Decision: Application HSC08013 Page 9 of 12 General Handling 11. Personal Protective Equipment (PPE), for example, safety glasses, gloves, waterproof clothing and protective clothing shall be worn when handling the substances, for example during handling, application and disposal. Trial Conditions 12. This approval applies only to the use of Everwood DF at Juken New Zealand’s Gisborne Mill. 13. The trials shall be undertaken in accordance with the Trial Plan which accompanied the application. Modifications to the Project Plan or Study Plans may only be made with the prior written approval of ERMA New Zealand. 14. The maximum total quantity of each Everwood DF that shall be imported under this approval is 150 L. 15. The trial facility shall incorporate containment precautions, such that the environment is not exposed to an Everwood DF-containing substance, in accordance with best practice. 16. Everwood DF shall be stored and mixed, prior to application in accordance with best practice. 17. Everwood DF shall only be in the production of plywood. Application of adhesive containing Everwood DF will be made in accordance with best practice. 18. Manufacture of Everwood DF-containing plywood shall be carried out in accordance with best practice. 19. During use Everwood DF shall be under the control of experimental staff that are trained and experienced in the handling and administration of the substances using the specified equipment. Experimental staff should also be aware of the trial conditions and the controls in place in order to adequately manage the substances. 20. No plywood manufactured using Everwood DF shall be sold, offered for sale, given away, bartered or otherwise distributed, except under the conditions detailed in control 21. 21. All plywood manufactured with Everwood DF (including waste and offcuts) will be exported to Japan for further experimentation and / or disposal. 22. A record shall be kept of all use of the substance. This record shall cover all matters referred to in Regulation 6(1) of the Hazardous Substances (Class 6, 8, and 9 Controls) Regulations 2001 and must be kept for not less than 3 years after the date on which the substance that the record relates to is applied or discharged. Emergency management 23. Any accidental spillage of the unmixed substance or diluted substance, and residue collected throughout the use of Everwood DF, shall be contained, prevented from entering waterways, and absorbed with an appropriate absorbent material. This material ERMA New Zealand Decision: Application HSC08013 Page 10 of 12 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. 24. 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. 25. 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. If a breach in containment results in contamination of a waterway, it is recommended that the relevant iwi authorities be advised. Disposal 26. All timber treated with Everwood DF shall be wrapped, sealed and palletised, and exported to Japan for testing and /or disposal. 27. Any equipment used and containers no longer used to contain Everwood DF shall be triple rinsed after use with water and if required with an appropriate detergent or decontaminant. The containers and rinsate shall be disposed of in a manner compliant with the Hazardous Substances (Disposal) Regulations 2001. 28. Surplus Everwood DF (or surplus glue to which Everwood DF has been added) remaining at completion of the trials shall be held in secure storage until exported from New Zealand and returned to the overseas supplier, or approval for release of Everwood DF has been obtained (completion is defined as the end of the trial programme as specified in the Trial Plan. Once the trials are complete the substance does not have approval to be present in New Zealand except in an exempt laboratory). Notification and Inspection 29. 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. Notifications shall include the following details: Substance name ERMA Application number ERMA Approval number ERMA Advisor (Hazardous Substances) Everwood DF HSC08013 HSC000 Matthew Allen 30. The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. ERMA New Zealand Decision: Application HSC08013 Page 11 of 12 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 HSC08013 Page 12 of 12