ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 24 December 2007 Application Code HSC07020 Application Type To manufacture hazardous substances in containment for export only purposes under Section 31 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Applicant Dow AgroSciences (NZ) Limited Purpose of the Application To import or manufacture Export Only Pesticides under containment for export where these substances fall within the hazard classification range 3.1 B-D, 6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A or B, or Class 9. Date Application Received 6 August 2007 Consideration Date 24 December 2007 Considered by Rob Forlong, Chief Executive of ERMA New Zealand 1 Summary of decision 1.1 The application to manufacture export-only pesticides in containment is approved with controls in accordance with the relevant provisions of the Act and the HSNO (Methodology) Order 1998 (“the Methodology”). 1.2 The substances have been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: Dow AgroSciences Export-only Pesticides 2 Legislative criteria for the 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 6 August 2007. 3.2 Evaluation of the application was undertaken by the ERMA New Zealand project team which comprised the following staff members: Noel McCardle Sekove Tinalevu Beth Dye 3.3 The applicant supplied the following documents: 3.4 Senior Advisor (Hazardous Substances) Advisor (Hazardous Substances) Applications Manager (Hazardous Substances) the application. 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 (Workplace Group); the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines Group (ACVM Group)). 3.4.1 No responses were received. 3.5 Due to delays in considering this application, the Authority, with the applicant’s consent, waived the requirement to consider this application by 17 September 2007 for an additional 67 working days. 3.6 The applicant was provided with a copy of the proposed controls for Export-only Pesticides and given the opportunity to comment on them. The comments provided were taken into account in the setting of 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 cover the contained manufacture of export-only pesticides for export to overseas markets. 4.4 Manufacture in this context means formulate from an imported pesticide active ingredient and other components which will have approvals under an ERMA New Zealand Group Standard. The export-only pesticides covered by this application will have a classification within the range 3.1 B-D, 6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A or B, Class 9; and ERMA New Zealand Decision: Application HSC07020 2 they will not be exported to the Pacific Islands. Export-only pesticides in the context of this application include ready to use adjuvants used in conjunction with a pesticide. 4.5 It is considered that the purpose of the application qualifies it to be considered under section 30(ca) as the substances will be formulated and packaged for export to a destination outside New Zealand. Life cycle of the substances 4.6 The applicant intends to manufacture the export-only pesticidal formulations in containment at its specialised and dedicated chemical formulation plant in New Plymouth. 4.7 The applicant has stated that the active ingredient components of the pesticides will be manufactured overseas and will be imported and transported by road or rail direct to the manufacturing site of Dow AgroSciences in New Plymouth. The importation will be in sealed containers with labels that comply with international transport requirements. If the material is a dangerous good it will be accompanied by the relevant documentation. The material will remain in the import containers during the subsequent road/rail transport to the Dow AgroSciences storage site in New Plymouth. This material will be used at the formulation site only. 4.8 The non-active components will be manufactured overseas and supplied to Dow AgroSciences by their New Zealand distributors by road/rail to the manufacturing site. The importation will be in sealed containers with labels that comply with international transport requirements. If the material is a dangerous good it will be accompanied by the relevant documentation. The material will remain in the import containers during the subsequent road/rail transport to the Dow AgroSciences storage site in New Plymouth. This material will be used at the formulation site only. 4.9 The export-only pesticides will be manufactured in batches, with each batch involving the mixing of the constituent components under ambient or heated conditions. Pressure may be required in the manufacturing process for some substances. Quality control procedures will be undertaken prior to the substance being packed. 4.10 The export-only pesticides will be manufactured at the Dow AgroSciences pesticide manufacturing plant for export purposes only. The transportation from the manufacturing site to the port of loading for export will be subject to the current land transport regulations and the HSNO controls applicable to the identified hazards. Packaging and storage would also comply with the relevant HSNO controls for the substance. 5 Hazardous properties of the substances 5.1 Dow AgroSciences has proposed that the substances be limited to those with classifications within the following boundaries: 3.1 B-D, 6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A or B, or Class 9. ERMA New Zealand Decision: Application HSC07020 3 6 Controls 6.1 Dow AgroSciences have proposed a set of controls for the management of the manufacture of export-only pesticides in containment at their New Plymouth site. The following risk assessment is based on the assumption that these controls together with others proposed by the Agency as set out in Appendix 1 are in place. 7 Identification and assessment of the significant risks of the manufacture of export-only pesticides 7.1 The applicant has identified and assessed potential risks associated with the manufacture of export-only pesticides 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. 7.2 As indicated in Paragraphs 4.7 and 4.8, the components used in the manufacture of export-only pesticides will be manufactured overseas and will be imported and transported by road or rail direct to the applicant’s manufacturing site in New Plymouth. The ingredients will be imported in sealed containers with labels that comply with international transport requirements and will be accompanied by the relevant documentation. The ingredients will remain in the import containers during the subsequent road/rail transport to the applicant’s storage site in New Plymouth. 7.3 Taking into account the transport regulations and controls such as packaging, identification and emergency management controls that will be imposed under this approval, it is considered that the importation of the active ingredient into containment in New Zealand will not pose any significant risks to the environment or human health and safety. Risks to the environment from the manufacture of export-only pesticides 7.4 Given the ecotoxic nature of the export-only pesticides, the project team considers them to have the potential to cause adverse effects to the biological environment if they enter the aquatic or terrestrial environments. 7.5 Due to the substances’ export-only status it is noted that the lifecycle stages occurring in New Zealand are limited; refer paragraphs 4.6 to 4.10. However, if an incident was to occur during one of those lifecycle stages, for example, transport to the port or shipping within New Zealand waters, there may be significant effects on the environment. It is noted that the overall impact would be largely dependent on the volume of the substance released and the susceptibility of the environment and organisms exposed. 7.6 In determining the overall level of risk posed to the environment while the substances are in New Zealand, the project team has taken several factors into account. These factors include the specialised nature of the manufacturing facilities; the trained, informed and equipped nature of the staff handling the substances; emergency management provisions; and the additional requirements of relevant legislation. An example of one of these factors is the provision of ERMA New Zealand Decision: Application HSC07020 4 bunding to contain spills during manufacture and storage, and the packing provisions that will act to limit the quantities released during a transport incident. 7.7 Given the factors described above, the project team considers that no significant risks will be posed to the environment. Risks to human health from the manufacture of export-only pesticides 7.8 The project team notes that exposure to the export-only pesticides poses a range of hazards to human health. The adverse effects may occur through one-off or repeated exposures. 7.9 It is considered that workers involved in handling the substances on a regular basis may be susceptible to both one-off and repeated exposures, while emergency workers and members of the public are only likely to experience oneoff (acute) exposures and are subsequently not at risk from the chronic hazards posed by the substances. 7.10 In determining the overall level of risk posed to human health while the substances are in New Zealand, the project team has taken several factors into account. These factors include the specialised nature of the manufacturing facilities; the trained, informed and equipped nature of the staff handling the substance; its highly restricted accessibility; and the additional requirements of relevant legislation. 7.11 Given the factors outlined above, the project team considers it unlikely that any significant risks will be posed to human health or welfare through the manufacture of export-only pesticides in New Zealand. Māori issues and concerns about manufacturing export-only pesticides 7.12 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. 7.13 As Dow AgroSciences Export-only Pesticides present several toxicity and ecotoxicity hazards the project team considers that the potential exists for the substance to deteriorate 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 Dow AgroSciences Export-only Pesticides to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways. 7.14 After careful consideration of the risks associated with the contained manufacture of Dow AgroSciences Export-only Pesticides 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. This assessment is made on the condition that the compounds are manufactured, 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 Dow ERMA New Zealand Decision: Application HSC07020 5 AgroSciences (NZ) Limited 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 7.15 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. 8 Containment and controls 8.1 The project team has evaluated the adequacy of the containment arrangements proposed by the applicant and has prepared 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: 8.2 to limit the likelihood of escape of any contained hazardous substances or contamination by hazardous substances (for example, control 6 c); to exclude organisms and unauthorised people from a facility (for example, control 6 a); to control the effects of any accidental release of the substance (for example, control 18); inspection and monitoring requirements (for example, control 8); and qualifications required of the person responsible for implementing the controls (for example, control 15). The project team is satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, export-only pesticides can be adequately contained within New Zealand. 9 Decision 9.1 Under section 32(1), I may approve a containment application made under section 31, 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. 9.2 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. 9.3 I have considered the application made by Dow AgroSciences (NZ) Limited, to manufacture the Dow AgroSciences export-only pesticides in containment for export only purposes. 9.4 I am satisfied that the application is for the purpose of “formulating, relabelling, repackaging or storing any hazardous substance for export to a destination outside New Zealand” as provided for in section 30(ca). 9.5 I have considered the risks associated with the substances’ 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 substances being adequately contained. ERMA New Zealand Decision: Application HSC07020 6 9.6 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: 9.7 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. I am satisfied that the requirements of section 32 have been met and thus approve the application made by Dow AgroSciences (NZ) Limited to manufacture Dow AgroSciences export-only pesticides in containment for export only purposes. This approval is subject to the controls as set out in Appendix 1. Rob Forlong Date 24 December 2007 Chief Executive of ERMA New Zealand Substance Identifier: ERMA New Zealand Approval Code: Dow AgroSciences Export-only Pesticides HSC000304 ERMA New Zealand Decision: Application HSC07020 7 APPENDIX 1: List of controls that apply to manufacture of Dow AgroSciences export-only pesticides Scope 1. This approval covers the contained manufacture, packing, storage and transport of pesticides (within the boundaries of 3.1 B-D, 6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A or B, or Class 9) by Dow AgroSciences (NZ) Limited in New Zealand for export-only purposes. 2. This approval excludes: a. the use of Dow AgroSciences Export-only pesticides in New Zealand. b. the manufacture for direct export from New Zealand to the Pacific Islands. c. any export-only pesticide which is a formulation that appears on the Chief Executive initiated reassessment priority list as listed in Appendix 2 and the formulation contains a derivative of a substance listed that is not already approved by the Authority. 3. This approval remains in force for five years from the date of this decision. Importation 4. Dow AgroSciences (NZ) Limited may import, in containment, the hazardous components used to manufacture Dow AgroSciences Export-only Pesticides at its manufacturing facility in New Plymouth. Manufacture 5. Dow AgroSciences (NZ) Limited may manufacture, in containment, the substances identified as Dow AgroSciences Export-only Pesticides, at its secure manufacturing facility in New Plymouth, as nominated in the application. 6. The facility used to store the hazardous components and manufacture and store export-only pesticides 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. Packaging 7. Dow AgroSciences Export-only Pesticides and their hazardous components shall be securely packed in suitable containers that comply with the Hazardous Substances (Packaging) Regulations 2001. Notification and inspection 8. If for any reason a breach of containment occurs in New Zealand, Dow AgroSciences (NZ) Limited shall, within 24 hours of the breach being detected: ERMA New Zealand Decision: Application HSC07020 8 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. 9. Documentation regarding the substances’ lifecycle, notwithstanding its confidential nature, shall be available for inspection by any authorised enforcement officer, upon request. 10. Prior to the commencement of manufacture, Dow AgroSciences shall provide ERMA New Zealand with a Notification to Manufacture. A Notification to Manufacture shall contain: a. The confidential composition of the substance; b. An SDS, for the export only pesticide and its hazardous components containing a HSNO hazard classification based upon the information contained therein; c. A registration approval notification from an importing country (or evidence from an importing country competent authority of an accepted application to register). Storage 11. The export-only pesticides and their hazardous components 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 12. The export-only pesticides and their hazardous components 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 13. Packages containing Dow AgroSciences Export-only Pesticides and their hazardous components shall be labelled in accordance with the Hazardous Substances (Identification) Regulations 2001 or in accordance with the alternative labelling requirements as set out below. Alternative labelling requirements for export-only substances Individual packages 1) The packaging of single containers of Dow AgroSciences Export-only Pesticides and their hazardous components, 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 Dow AgroSciences Export-only Pesticides the labelling that meets the requirements of the Australian Pesticides and Veterinary Medicines Authority (APVMA) is recognised by ERMA New Zealand. ERMA New Zealand Decision: Application HSC07020 9 ii) For imported hazardous components, labels that meet the requirements of Australia, USA and the EU for the transport of chemicals. 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, 14, 18, 20, 25, or 36(8) of the Hazardous Substances (Identification) Regulations 2001. Multiple packaging 1) These requirements apply to Dow AgroSciences Export-only Pesticides and their hazardous components 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 requirements Globally Harmonised System; or c) 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 d) the pictogram for “Dangerous in the Environment” as described in directive 92/32/EEC (instead of identifier requirements of regulations 9 and 20); or e) 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 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, 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. ERMA New Zealand Decision: Application HSC07020 10 Safety data sheets 14. A Safety Data Sheet (SDS), compliant with the Hazardous Substances (Identification) Regulations 2001 shall be present with the substances at all stages of their lifecycles in New Zealand. The SDS shall be available within 10 minutes. Handling of the substances 15. Persons handling Dow AgroSciences Export-only Pesticides and their hazardous components during manufacture and packing shall have received training in the safe handling and management of hazardous chemicals or be under the supervision of persons with this knowledge. 16. Appropriate Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective clothing shall be worn by persons handling the substances during manufacture, packing and disposal. 17. Workplace Exposure Standards set by the Department of Labour for any of the components of Dow AgroSciences Export-only Pesticides shall apply. Emergency management 18. Dow AgroSciences (NZ) Limited shall comply with the emergency management provisions as required by regulations 25 to 42 of the Hazardous Substances (Emergency Management) Regulations 2001. Disposal 19. If Dow AgroSciences Export-only Pesticides or their hazardous components require disposal in New Zealand, Dow AgroSciences shall dispose of them in a manner compliant with the requirements of the Hazardous Substances (Disposal) Regulations 2001. 20. Any rinsate, washings, or residue generated during the manufacture of Dow AgroSciences Export-only Pesticides 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 HSC07020 11 APPENDIX 2: List of substances that are excluded from the scope of this approval. Endosulfan and its formulations Azinphos methyl and its formulations Methyl-parathion and its formulations Pentachlorophenol and its salts 2,4-D, its salts and esters and formulations containing these substances Acephate and its formulations Anti-fouling paints Benomyl and carbendazim and their formulations Carbaryl and its formulations Chlorothalonil and its formulations Chlorpyrifos and its formulations; Diazinon and its formulations Dichlorvos and its formulations Dimethoate and its formulations Fenitrothion and its formulations Methamidophos (60%) and its formulations Methyl bromide Methyl-arsenic acid and its formulations Paraquat and its formulations Trichlorfon and its formulations ERMA New Zealand Decision: Application HSC07020 12