ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 21 March 2007 Application code: HSR06104 Application Type To import or manufacture any hazardous substance under Section 28A(2)(b) of the Hazardous Substances and New Organisms Act 1996 (the Act) [rapid assessment (low hazard)] Applicant: Primaxa Ltd Purpose of the Application Checkmate CM-F capsule suspension formulation: approval to import or manufacture as an insect mating disruption pheromone. (low hazard) Date application received: 18 January 2007 Consideration Date 21 March 2007 Considered by Rob Forlong (Chief Executive, ERMA New Zealand) 1 Summary of decision 1.1 The application to import or manufacture Checkmate CM-F for release is approved with the controls as set out in Appendix 1. This approval has been given in accordance with the relevant provisions of the Act, the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology), based on Checkmate CM-F being formulated so that the substance has one or more hazardous properties and each hazardous property has the least degree of hazard for that property. 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: Checkmate CM-F 2 Legislative criteria for the application 2.1 The application was lodged pursuant to section 28. The decision was determined in accordance with section 28A(2)(b), taking into account the requirements of that section and matters specified under Part II 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 purpose of this application is to gain approval to import or manufacture Checkmate CM-F as an insect mating disruption pheromone. 3.2 The application was formally received on 18 January 2007. 3.2.1 3.3 The Agricultural Compounds & Veterinary Medicines Group (ACVMG) of the New Zealand Food Safety Authority (NZFSA) and the Department of Labour Workplace Group were advised of the application (clause 2(2)(e)). 3.3.1 3.4 3.5 The application timeframe was extended by 29 working days as the result of a request for further information under section 58. No responses were received. Evaluation of the application was undertaken by the ERMA New Zealand project team which comprised the following staff members: Margaret Keane Advisor (Hazardous Substances) Tania van Maanen Advisor (Hazardous Substances) Zack Bishara Advisor (Maori Unit) Beth Dye Applications Manager (Hazardous Substances) The application was considered by the Chief Executive of ERMA New Zealand as provided for by a delegation from the Authority under section 19(2)(d). 4 Consideration Sequence of the consideration 4.1 Primaxa Ltd seeks approval, under section 28, to import or manufacture Checkmate CM-F for release in New Zealand. 4.2 An application can be assessed by rapid assessment procedures, under section 28A(2)(b), if it can be shown that Checkmate CM-F has been formulated so that the substance has one or more hazardous properties and each hazardous property has the least degree of hazard for that property. 4.3 The approach adopted when considering this application was: to identify the composition and hazardous properties of the proposed substance, Checkmate CM-F; to determine whether Checkmate CM-F has been formulated so that it has one or more hazardous properties and each hazardous property has the least degree of hazard for that property. 4.4 And then: to consider whether there are any other effects that mean Checkmate CM-F should not be rapidly assessed; and to consider whether the controls that apply under the Act will prevent or manage the adverse effects of the substance. Environmental Risk Management Authority Decision: Application HSR06104 Page 2 of 25 Information review 4.5 The project team has reviewed the information supplied by Primaxa Ltd, and considers that the information constitutes an adequate and appropriate basis for assessing the application (clause 8). They also consider that there are no significant uncertainties (ie sufficient to influence decision making) in the scientific and technical information relating to the risks of Checkmate CM-F (clauses 29 and 30). Composition of Checkmate CM-F 4.6 Checkmate CM-F is a capsule suspension formulation containing the active component 8,10-dodecadien-1-ol, a synthetic copy of the natural sex pheromone, codlemone, produced by the Codling moth Cydia pomonella. Codlemone is found naturally in the environment, in places such as pip fruit orchards (apples and pears), where it is released by the female codling moth to attract the male moth for mating purposes. Hazardous properties of Checkmate CM-F 4.7 The project team has determined the hazard profile of Checkmate CM-F based on the information provided by the applicant and other available information. The hazard classifications for Checkmate CM-F are set out in Table 4.1. Table 4.1: Hazard classifications Hazard Endpoint Checkmate CM-F Skin Irritation/Corrosion Aquatic Ecotoxicity 4.8 6.3B 9.1D Checkmate CM-F is classified as 6.3B (mild skin irritant) and 9.1D (slightly harmful to the aquatic environment). Meeting the criteria for rapid assessment under section 28A(2)(b) 4.9 Based on the above information, the project team considers that the criteria for rapid assessment under section 28A(2)(b) have been met through Checkmate CM-F being formulated so that it has two hazardous properties and each hazardous property has the least degree of hazard for that property. 4.10 The project team considers that there are no other matters which would prevent this application for Checkmate CM-F from being rapidly assessed. Use of Checkmate CM-F 4.11 Checkmate CM-F is intended to be applied to apple and pear trees to disrupt mating of the codling moth by confusing the males and preventing them from detecting the pheromone of mating females. The product will only affect adult male moths and will have no effect on female moths, eggs or larvae. 4.12 The applicant notes that the synthetic sex pheromone codlemone is currently used in New Zealand orchards but it is contained in plastic dispensers which are hung in the apple or pear orchards, releasing the codlemone slowly into the air over a period of months. Environmental Risk Management Authority Decision: Application HSR06104 Page 3 of 25 4.13 Checkmate CM-F is formulated as a capsule suspension in water and is diluted with water prior to spraying. The precise methods and rates of application are detailed in Confidential Appendix 4. 4.14 Checkmate CM-F is added to water in a spraying rig and applied to the target crop as and when required. 5 Controls Default controls 5.1 Based on the hazard classifications determined for the proposed substance, a set of associated default controls has been identified by the project team as being applicable to Checkmate CM-F. These default controls, expressed as control codes1, are listed in Table 5.1. 5.2 Additional controls under section 77A are available to manage the risks associated with Checkmate CM-F, which are not addressed by the default controls. These are considered in Paragraph 5.4 below. Table 5.1: List of default controls for Checkmate CM-F Toxicity Controls T1 Limiting exposure to toxic substances through the setting of TELs T2 Controlling exposure in places of work through the setting of WESs. T4 Requirements for equipment used to handle substances T7 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles Ecotoxicity Controls E1 Limiting exposure to ecotoxic substances through the setting of EELs E2 Restrictions on use of substances in application areas E6 Requirements for equipment used to handle substances Identification Controls I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability I9 Secondary identifiers for all hazardous substances I11 Secondary identifiers for ecotoxic substances I16 Secondary identifiers for toxic substances I19 Additional information requirements, including situations where substances are in multiple packaging I21 General documentation requirements I28 Specific documentation requirements for toxic substances I29 Signage requirements Packaging Controls P1 General packaging requirements P3 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria P13 Packaging requirements for toxic substances PS4 Packaging requirements as specified in Schedule 4 (packaging regulations) Disposal Controls Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A detailed list of these codes is contained in the ERMA New Zealand User Guide to the Controls Regulations. 1 Environmental Risk Management Authority Decision: Application HSR06104 Page 4 of 25 D4 D5 D6 D7 Disposal requirements for toxic and corrosive substances Disposal requirements for ecotoxic substances Disposal requirements for packages Information requirements for manufacturers, importers and suppliers, and persons in charge D8 Documentation requirements for manufacturers, importers and suppliers, and persons in charge Emergency Management Controls EM1 Level 1 information requirements for suppliers and persons in charge EM6 Information requirements for toxic substances EM7 Information requirements for ecotoxic substances EM8 Level 2 information requirements for suppliers and persons in charge EM11 Level 3 emergency management requirements: duties of person in charge, emergency response plans EM12 Level 3 emergency management requirements: secondary containment EM13 Level 3 emergency management requirements: signage Tank Wagon and Transportable Containers Controls The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers. Additional controls under section 77A 5.3 Under section 77A, the Authority may impose as controls any obligations and restrictions that the Authority thinks fit. Before imposing a control under this section, the Authority must be satisfied that, against any other specified controls applying to Checkmate CM-F: (a) the proposed control is more effective in terms of its effect on the management, use and risks of hazardous substances; or (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of hazardous substances; or (c) the proposed control is more likely to achieve its purpose. 5.4 The following control additions have been proposed for Checkmate CM-F by the Project Team: 5.4.1 The project team notes that, unless specifically allowed for, pesticides should not be applied into or onto water. As the default controls do not prohibit such use, the project team considers that the following control should be applied to Checkmate CM-F as being more effective in terms of its effect on the use of the substance than the default controls: Checkmate CM-F shall not be applied directly onto or into water. 5.4.2 The project team notes that the default controls do not address risks associated with stationary container systems nor do they allow for dispensation where it is unnecessary for any associated pipework to have secondary containment. Accordingly, the project team considers that the application of controls addressing these risks will be more effective than the default controls in terms of their effect on the management, use and risks of the substance. Such controls were applied to pesticides on transfer to the HSNO regime. The project team considers that these controls are similarly appropriate for the management of the risks associated with Checkmate CM-F and proposes that the following controls should be applied to the substance: Environmental Risk Management Authority Decision: Application HSR06104 Page 5 of 25 The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances (Dangerous Goods and 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 Schedule 8. 5.4.3 The project team considers that the following subclauses should be added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. Variation of controls under section 77 5.5 Under section 77, the default controls triggered for the substance may be varied. Under section 77(3), controls may be substituted or added, under section 77(4), controls may be substituted or deleted; and under section 77(5), where a substance triggers more than one hazard classification, controls may be combined. 5.6 The following variations have been proposed for Checkmate CM-F by the project team: 5.6.1 Control T1 relates to limiting exposure to toxic substances through the setting of Tolerable Exposure Limits (TELs). Following the passing of the Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005, the Agency is intending to review the setting of ADEs, PDEs and TELs under section 77B. Until this review is complete, the project team proposes that ADEs, PDEs or TELs are not set for any components of Checkmate CM-F. 5.6.2 Control T2 relates to the requirement to set Workplace Exposure Standards (WESs). The project team notes that no Department of Labour values have been set for any of the components of Checkmate CM-F. It is further noted that the conditions of Regulation 29(1)(c) are not met as there is insufficient industrial hygiene data available to enable a WES to be set for any constituent components. It is therefore considered that this control should not be applied to the substance. 5.6.3 Control E1 relates to limiting exposure to toxic substances through the setting of Environmental Exposure Limits (EELs). Following the implementation of the Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005, the Agency is intending to review Environmental Risk Management Authority Decision: Application HSR06104 Page 6 of 25 the setting of EELs under section 77B. Until this review is complete, the project team proposes that EELs are not set for any components of Checkmate CM-F at this time. It is also proposed that the default EELwater value be deleted. 5.7 5.6.4 Control E2 relates to restrictions on use within an application area when an EEL has been set. As no EELs have been set, no application rates are proposed by the project team at this time. 5.6.5 The project team considers that controls T4 and E6 may be combined under section 77(5) as they both relate to requirements for equipment used to handle Checkmate CM-F. 5.6.6 The project team considers that controls P3 and P13 may be combined under section 77(5) as they both relate to packaging requirements for Checkmate CM-F. 5.6.7 The project team considers that controls D4 and D5 may be combined under section 77(5) as they both relate to disposal requirements for Checkmate CM-F. The modifications to controls, as above, have been incorporated into the list of controls for Checkmate CM-F detailed in Appendix 1. 6 Assessment of the adverse effects 6.1 The project team has evaluated the potential of Checkmate CM-F to cause adverse effects to human health and the environment (non-target organisms) during all stages of the substance’s lifecycle. A qualitative risk assessment was carried out to assess the risks to human health (refer Appendix 2 for qualitative descriptors of risk) and both a qualitative and quantitative assessment was carried out to assess risks to the environment. Assessment of risks to human health 6.2 The project team considers the risks to human health arising from the mild skin irritancy hazard (6.3B) presented by Checkmate CM-F to be insignificant. This assessment is based on the following considerations: 6.2.1 The project team considers it is highly improbable, given adherence to HSNO controls (e.g. packaging, identification, emergency management and disposal), transport regulations and the Resource Management Act 1991 (the RMA), that a spillage of Checkmate CM-F will occur and result in adverse effects on people when the substance is being transported, stored or disposed of. 6.2.2 The project team considers it is improbable, given adherence to HSNO controls (e.g. packaging, identification and emergency management) and the Health and Safety in Employment Act 1992 (the HSE Act) requirements, that workers will be adversely affected by Checkmate CM-F during its manufacture. 6.2.3 The project team considers it is improbable, given adherence to HSNO controls (e.g. equipment, packaging, identification and emergency management), adherence to the Code of Practice for the Management of Agrichemicals NZS: 8409:2004, and the requirements of the RMA and the HSE Act, that users of Checkmate CM-F will be adversely affected by the substance when applying it. Environmental Risk Management Authority Decision: Application HSR06104 Page 7 of 25 6.2.4 The project team considers it is improbable, taking into consideration adherence to the Code of Practice for the Management of Agrichemicals NZS: 8409:2004, and the requirements of the RMA, that bystanders will be adversely affected through spray drift. 6.2.5 The project team considers that if exposure were to occur, the magnitude of any adverse effect will be minimal as the effect would be limited to the exposed individuals and be of a relatively short term and mild in nature. Assessment of risks to the environment 6.3 Quantitative modelling of risks to the environment arising from the use of Checkmate CM-F has been carried out and is presented in Appendix 3. The acute risk quotients derived from this assessment are significantly below the level of concern for fish, crustacean and algae, suggesting that the use of Checkmate CM-F will not pose a high acute aquatic risk. As no chronic ecotoxicity data was available for 8,10-dodecadien-1-ol, no estimation was able to be made of chronic risk. However, it is noted that the available data on 8,10-dodecadien-1-ol suggests it will be readily degradable in the environment, and will not bioaccumulate. Consequently, the project team consider it highly improbable that the use of Checkmate CM-F will pose a risk to the environment. 6.4 A qualitative risk assessment was carried out by the project team to consider the risks to the environment during life-cycle stages other than use. These risks are considered to be insignificant based on the following considerations: 6.4.1 The project team considers that it is highly improbable given adherence to HSNO controls (e.g. packaging, identification and emergency management), transport regulations and the RMA, that the aquatic environment will be exposed to Checkmate CM-F during manufacture, transport, storage or disposal in such a manner so as to cause any adverse effects. 6.4.2 If exposure were to occur, the project team considers that the magnitude of any adverse effect will be minimal to minor as the effect would be localised with no discernible ecosystem impact. Assessment of issues and concerns to Māori 6.5 After careful consideration of the information provided by the applicant and the project team’s scientific evaluation, Kaupapa Kura Taiao is not aware of any likely impact that Checkmate CM-F could have on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. 6.6 This assessment is made on the condition that the substance is handled, blended, stored, transported, used and disposed of, in accordance with the explicitly stated HSNO controls, and any controls stipulated in other applicable Acts. However, should inappropriate use, or an accident, result in the contamination of waterways or the environment, it is encouraged that the appropriate authorities including the relevant iwi authorities in that region be informed. This action should include advising them of the contamination and the measures taken to contain and remedy it. Environmental Risk Management Authority Decision: Application HSR06104 Page 8 of 25 7 Environmental user charges 7.1 The project team considers that use of controls on Checkmate CM-F is an effective means of managing risks associated with this substance. At this time, no consideration has been given to whether or not environmental charges should be applied to this substance as an alternative or additional means of achieving effective risk management. Accordingly, no report has been made to the Minister for the Environment. 8 Decision 8.1 Pursuant to section 28A, I have considered this application to import or manufacture a hazardous substance for release made under section 28. 8.2 Having considered the composition, hazardous properties, and use for Checkmate CM-F, I am satisfied that the proposed substance meets the criteria for rapid assessment under section 28A(2)(b) in that it has been formulated so that the substance has one or more hazardous properties and each hazardous property has the least degree of hazard for that property. 8.3 Because the risks posed by the Checkmate CM-F are insignificant, I consider that applying the HSNO default controls to Checkmate CM-F, with the additions and amendments proposed under paragraphs 5.4 to 5.6.7 (inclusive), will ensure adequate management of any adverse effects of Checkmate CM-F. 8.4 In this consideration, I have also applied the following criteria in the Methodology: clause 9 – equivalent of sections 5, 6 and 8; clause 12 – risk assessment; clause 21 – the decision accords with the requirements of the Act and regulations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; and clause 35 – the costs and benefits of varying the default controls. 8.5 The application for importation and manufacture of the hazardous substance, Checkmate CM-F for release is thus approved with controls as detailed in Appendix 1. Rob Forlong Chief Executive, ERMA New Zealand Date: 21 March 2007 Checkmate CM-F ERMA New Zealand Approval Code: Environmental Risk Management Authority Decision: Application HSR06104 HSR007766 Page 9 of 25 Appendix 1: Controls applying to Checkmate CM-F The controls imposed on Checkmate CM-F are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New Zealand publication “User Guide to Control Regulations” provides useful guidance on the controls. Table A1.1: Controls applying to Checkmate CM-F 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 This control relates to limiting public exposure to toxic substances through the setting of tolerable exposure limits (TELs). No TELs are set for Checkmate CM-F at this time. T4, E6 7 Requirements for equipment used to handle hazardous substances Any equipment used to handle Checkmate CM-F (e.g. spray equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved. T7 10 Restrictions on the carriage of hazardous substances on passenger service vehicles The maximum quantity per package of Checkmate CM-F permitted to be carried on passenger service vehicles is 10 L. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 Limiting exposure to ecotoxic substances This control relates to the setting of environmental exposure limits (EELs). No EELs are set for Checkmate CM-F at this time. E2 46-48 Restrictions on use within application area These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6/E7, Regulation 9) do not apply once the substance has been applied or laid. No application rates are set for Checkmate CM-F at this time. 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. 1 Environmental Risk Management Authority Decision: Application HSR06104 Page 10 of 25 Control Code1 Regulation2 Explanation3 Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of Checkmate CM-F in terms of: information that must be “immediately available” with the substance (priority and secondary identifiers). This information is generally provided by way of the product label; documentation that must be available in the workplace, generally provided by way of SDS; signage at a place where there is a large quantity of the substance. I1 6, 7, 32-35, 36 General identification requirements (1)-(7) These controls relate to the duties of suppliers and persons in charge of Checkmate CM-F with respect to identification (essentially labelling) (Regulations 6 and 7), accessibility of the required information (Regulations 32 and 33) and presentation of the required information with respect to comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7)) Regulation 6 – Identification duties of suppliers Suppliers of Checkmate CM-F must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8-17) and secondary identifier information (as required by Regulations 18-30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling Checkmate CM-F within two seconds (Regulation 32), and the secondary identifier information available within 10 seconds (Regulation 33). Suppliers must also ensure that no information is supplied with Checkmate CM-F (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulation 7 – Identification duties of persons in charge Persons in charge of Checkmate CM-F must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling Checkmate CM-F within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds, e.g. on the label. All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, e.g. on the label. Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily understandable and in English; Environmental Risk Management Authority Decision: Application HSR06104 Page 11 of 25 Control Code1 Regulation2 I9 18 I11 20 I16 25 I19 29-31 Explanation3 any information provided in written or pictorial form must be able to be easily read or perceived by a person with average eyesight under normal lighting conditions; any information provided in an audible form must be able to be easily heard by a person with average hearing; any information provided must be in a durable format i.e. the information requirements with respect to clarity must be able to be met throughout the lifetime of the (packaged) substance under the normal conditions of storage, handling and use. Secondary identifiers for all hazardous substances This control relates to detail required for Checkmate CM-F on the product label. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information is required: an indication (which may include its common name, chemical name, or registered trade name) that unequivocally identifies it; and enough information to enable its New Zealand importer, supplier, or manufacturer to be contacted, either in person or by telephone; and in the case of a substance which, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class or subclass, a description of each likely change and the date by which it is likely to occur. Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for Checkmate CM-F. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of the circumstances in which it may harm living organisms; an indication of the kind and extent of the harm it is likely to cause to living organisms; an indication of the steps to be taken to prevent harm to living organisms; an indication of its general type and degree of hazard (ie ecotoxic in the aquatic environment). Secondary identifiers for toxic substances This control relates to the additional label detail required for Checkmate CM-F. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of toxic hazard (ie skin irritancy); an indication of the circumstances in which it may harm human beings; an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm; an indication of the steps to be taken to prevent harm to human beings. Alternative information in certain cases Regulation 29 – Substances in fixed bulk containers or bulk transport containers This Regulation relates to alternative ways of presenting the priority and secondary identifier information required by Regulations 8 to 25 when Checkmate CM-F is contained in fixed bulk containers or bulk transport containers. Environmental Risk Management Authority Decision: Application HSR06104 Page 12 of 25 Control Code1 Regulation2 Explanation3 Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if the substance is labelled or marked in compliance with the requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. Regulation 30 – Substances in multiple packaging This Regulation relates to situations when Checkmate CM-F is in multiple packaging and the outer packaging obscures some or all of the required substance information. In such cases, the outer packaging must: be clearly labelled with all relevant priority identifier information i.e. the hazardous properties of the substance must be identified; or be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant; or in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background); or bear the relevant class or subclass label assigned by the UN Model Regulations. I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for Checkmate CM-F that is imported into New Zealand in a closed package or in a freight container and will be transported to its destination without being removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is labelled or marked in compliance with the requirements of the Land Transport Rule 45001. Documentation required in places of work These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets) (Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when Checkmate CM-F is held in the workplace in quantities equal to or greater than 50 L. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity of Checkmate CM-F equal to or greater than 50 L, if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where Checkmate CM-F is present in quantities equal to or greater than those specified in Regulation 38 (and with reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation required for each hazardous substance concerned. The person in charge must also Environmental Risk Management Authority Decision: Application HSR06104 Page 13 of 25 Control Code1 Regulation2 Explanation3 ensure that the documentation does not contain any information that suggests that the substance belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with a hazardous substance must include the following information: the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); a description of the physical state, colour and odour of the substance; if the Checkmate CM-F’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the changes in physical state may occur and the nature of those changes; in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur; contact details for the New Zealand supplier / manufacturer /importer; all emergency management and disposal information required for the substance; the date on which the documentation was prepared. Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (e.g. as provided on an SDS). If information required by Regulations 39 to 46 was not included in the information used for the approval of the substance by the Authority, it is sufficient compliance with those Regulations if reference is made to that information requirement along with a comment indicating that such information is not applicable to that substance. Regulation 48 – Location and presentation requirements for documentation All required documentation must be available to a person handling Checkmate CM-F in a place of work within 10 minutes. The documentation must be readily understandable by any fully-trained worker required to have access to it and must be easily read, under normal lighting conditions, at a distance of not less than 0.3 m. Regulation 49 – Documentation requirements for vehicles This Regulation provides for the option of complying with documentation requirements as specified in the various Land, Sea and Air transport rules when the substance is being transported. I28 46 Regulation 50 – Documentation to be supplied on request Notwithstanding Regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where Checkmate CM-F is present) if asked to do so by that person. Specific documentation requirements for toxic substances The documentation provided with Checkmate CM-F must include the following information: its general degree and type of toxic hazard (ie skin irritancy); a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; Environmental Risk Management Authority Decision: Application HSR06104 Page 14 of 25 Control Code1 Regulation2 I29 51-52 Explanation3 a full description of the steps to be taken to prevent harm to human beings; the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured; a summary of the available acute and chronic (toxicity) data used to define the (toxic) subclass or subclasses in which it is classified; the symptoms or signs of injury or ill health associated with each likely route of exposure; the dose, concentration, or conditions of exposure likely to cause injury or ill health; any TELs or WESs set by the Authority. Duties of persons in charge of places with respect to signage These controls specify the requirements for signage, in terms of content, presentation and positioning at places where Checkmate CM-F is held in quantities exceeding 10,000 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where Checkmate CM-F is present at each entrance to rooms or compartments where Checkmate CM-F is present; immediately adjacent to the area where Checkmate CM-F is located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (ie skin irritancy, ecotoxic in the aquatic environment); where the signage is immediately adjacent to Checkmate CM-F storage areas, describe the precautions needed to safely manage the substance. Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for Checkmate CM-F must ensure that, when the package is closed, there is no visible release of the substance, and that it maintains its ability to retain its contents in temperatures from –10oC to +50oC. The packaging must also maintain its ability to retain its remaining contents if part of the contents is removed from the package and the packaging is then re-closed. The packaging in direct contact with Checkmate CM-F must not be significantly affected or weakened by contact with the substance such that the foregoing requirements cannot be met. Regulation 6 – Packaging markings Packages containing hazardous substances must not be marked in accordance with the UN Model Regulations unless: the markings comply with the relevant provisions of that document; and the design of the packaging has been test certified as complying with those Environmental Risk Management Authority Decision: Application HSR06104 Page 15 of 25 Control Code1 Regulation2 Explanation3 tests. Regulation 7(1) – Requirements when packing hazardous substance When packing Checkmate CM-F, account must be taken of its physical state and properties, and packaging must be selected that complies with the requirements of Regulation 5, and Regulations 9 to 21. Regulation 8 – Compatibility Checkmate CM-F must not be packed in packaging that has been previously packed with substances with which it is incompatible unless all traces of the previous substance have been removed. Regulation 9A and 9B – Large Packaging Large packaging may be used to contain hazardous substances in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. P3, P13 9, 19 “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004; or a stationary container system, a stationary tank or a tank (as defined in the Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for Checkmate CM-F Checkmate CM-F must be packaged in packaging that complies with Schedule 4 of the Packaging Regulations. However, there is provision that packages containing less than 0.5 L of Checkmate CM-F do not have to comply with the drop test performance standard contained in Schedule 4 provided the packaging complies with the requirements of regulations 5(1) (a), (b) and (e), and there is a warning statement on the outside of the package that the package may not withstand a drop of 0.5 m [Regulation 9 (3), (4), and (5)]. PS4 Schedule 4 Checkmate CM-F offered for sale in a package of less than 2.5L must be in child resistant packaging (i.e. toxic substances liable to be in homes). However, if the substance is for use in a place of work to which children do not have access, this requirement is not mandatory. This schedule describes the minimum packaging requirements that must be complied with for Checkmate CM-F. Environmental Risk Management Authority Decision: Application HSR06104 Page 16 of 25 Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for toxic and corrosive substances Checkmate CM-F must be disposed of by: treating it so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to discharge to the environment; or discharging it to the environment provided that after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone does not exceed any TEL (tolerable exposure limit) or any EEL (environmental exposure limit) set by the Authority for that substance; or exporting it from New Zealand as a hazardous waste. D6 10 Disposal requirements for packages This control gives the disposal requirements for packages that contained Checkmate CM-F and are no longer to be used for that purpose. Such packages must be either decontaminated/treated or rendered incapable of containing any substance (hazardous or otherwise) and then disposed of in a manner that is consistent with the disposal requirements for the substance. In addition, the manner of disposal must take into account the material that the package is manufactured from. D7 11, 12 Disposal information requirements These controls relate to the provision of information concerning disposal (essentially on the label) that must be provided when selling or supplying a quantity of Checkmate CM-F that exceeds 1.0 L. D8 13, 14 Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, i.e. which would not comply with the Disposal Regulations. Such information must be accessible to a person handling Checkmate CM-F within 10 seconds and must comply with the requirements for comprehensibility, clarity and durability as described in Regulations 34-36 of the Identification Regulations (code I1). Disposal documentation requirements These controls relate to the provision of documentation concerning disposal (essentially in an SDS) that must be provided when selling or supplying a quantity of Checkmate CM-F that exceeds 50 L. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling Checkmate CM-F at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in Regulations 48(2), (3) and (4) of the Identification Regulations (code I21). Hazardous Substances (Emergency Management) Regulations 2001 EM1 6, 7, 9-11 Level 1 emergency management information: General requirements These controls relate to the provision of emergency management information (essentially on the label) that must be provided with Checkmate CM-F when present in quantities equal to or greater than 1.0 L. Regulation 6 describes the duties of suppliers, Regulation 7 describes the duties of persons in charge of places, Regulation 9 describes the requirement for the availability of the information (10 seconds) and Regulation 10 gives the requirements relating to the presentation of the information with respect to comprehensibility, clarity and durability. These requirements correspond with Environmental Risk Management Authority Decision: Application HSR06104 Page 17 of 25 those relating to secondary identifiers required by the Identification Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)). EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. Information requirements for toxic substances The following information must be provided when Checkmate CM-F is present in quantities equal to or greater than 1.0 L: a description of the first aid to be given; a 24-hour emergency service telephone number. Information requirements for ecotoxic substances The following information must be provided with Checkmate CM-F when present in quantities equal to or greater than 1.0 L: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent Checkmate CM-F from entering or affecting those parts of the environment. Level 2 emergency management documentation requirements These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Safety Data Sheets). This documentation must be provided where Checkmate CM-F is sold or supplied, or held in a workplace, in quantities equal to or greater than 50 L. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM11 EM12 25-34 35-41 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where Checkmate CM-F is held (or reasonably likely to be held on occasion) in quantities greater than 10,000 L. The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be included in the plan is specified in Regulations 29 to 30. Requirements relating to the availability of equipment, materials and people are provided in Regulation 31, requirements regarding the availability of the plan are provided in Regulation 32 and requirements for testing the plan are described in Regulation 33. Level 3 emergency management requirements – secondary containment These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where Checkmate CM-F is held in quantities equal to or greater than 10,000 L. Environmental Risk Management Authority Decision: Application HSR06104 Page 18 of 25 Regulation 36 prescribes requirements for secondary containment systems for pooling substances. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60 L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60 L and 450 L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450 L. Regulation 40 prescribes requirements for places where hazardous substances are held underground. Regulation 41 prescribes requirements for secondary containment systems that contain substances of specific hazard classifications. The following subclauses shall be added after subclause (3) of regulation 36: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. EM13 42 Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where Checkmate CM-F is held at quantities equal to or greater than 10,000 L. The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the Identification Regulations. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 The Hazardous Substances (Tank Wagons and Transportable Containers) where applicable Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Additional controls set under s77A Checkmate CM-F shall not be applied directly onto or into water. The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances (Dangerous Goods and 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. EM12: see the control explanation for additional subclauses. Environmental Risk Management Authority Decision: Application HSR06104 Page 19 of 25 Appendix 2: Qualitative scales for describing effects Qualitative descriptors Qualitative descriptors are indicative only and they are primarily intended to be used to rank risks and benefits for the purposes of balancing risks and costs against benefits, and so that risks can be prioritised for management. The ‘descriptor’ words should not be seen in any absolute senses – they are simply a means of differentiating levels of significance. Table A2.1: Likelihood (adverse effect) Descriptor Description 1 Highly improbable Almost certainly not occurring but cannot be totally ruled out 2 Improbable (remote) Only occurring in very exceptional circumstances. 3 Very unlikely Considered only to occur in very unusual circumstances 4 Unlikely (occasional) Could occur, but is not expected to occur under normal operating conditions. 5 Likely A good chance that it may occur under normal operating conditions. 6 Very likely Expected to occur if all conditions met 7 Extremely likely Almost certain Table A2.2: Magnitude of adverse effect (risks and costs) Descriptor Examples of descriptions I Minimal Mild reversible short term adverse health effects to individuals in highly localised area Highly localised and contained environmental impact, affecting a few (less than ten) individuals members of communities of flora or fauna, no discernible ecosystem impact Low dollar cost of containment/cleanup/repair (<$5,000) No social disruption1 II Minor Mild reversible short term adverse health effects to identified and isolated groups2 Localised and contained reversible environmental impact, some local plant or animal communities temporarily damaged, no discernible ecosystem impact or species damage Dollar cost of containment/cleanup/repair in order of $5,000-$50,000 Potential social disruption (community placed on alert) III Moderate Minor irreversible health effects to individuals and/or reversible medium term adverse health effects to larger (but surrounding) community (requiring hospitalisation) Measurable long term damage to local plant and animal communities, but no obvious spread beyond defined boundaries, medium term individual ecosystem damage, no species damage Dollar cost of containment/cleanup/repair in order of $50,000-$500,000, Some social disruption (e.g. people delayed) IV Major Significant irreversible adverse health effects affecting individuals and requiring hospitalisation and/or reversible adverse health effects reaching beyond the immediate community Long term/irreversible damage to localised ecosystem but no species loss Dollar cost of containment/cleanup/repair in order of $500,000-$5,000,000 Social disruption to surrounding community, including some evacuations V Massive Significant irreversible adverse health effects reaching beyond the immediate community and/or deaths 1 2 The concept of social disruption includes both physical disruption, and perceptions leading to psychological disruption. For example, some chemicals may have nuisance effects (through odour) that result in communities feeling threatened. Note that the reference to ‘groups’ and ‘communities’ in the context of human health effects includes the notion of groups defined by health status. Environmental Risk Management Authority Decision: Application HSR06104 Page 20 of 25 Extensive irreversible ecosystem damage, including species loss Dollar cost of containment/cleanup/repair greater than $5,000,000 Major social disruption with entire surrounding area evacuated and impacts on wider community Table A2.3: Magnitude of beneficial effect (benefits) Descriptor Examples of descriptions I Minimal Mild short term positive health effects to individuals in highly localised area Highly localised and contained environmental impact, affecting a few (less than ten) individuals members of communities of flora or fauna, no discernible ecosystem impact Low dollar benefit (<$5,000) No social effect II Minor Mild short term beneficial health effects to identified and isolated groups Localised and contained beneficial environmental impact, no discernible ecosystem impact or species damage Dollar benefit in order of $5,000-$50,000 Minor localised community benefit III Moderate Minor health benefits to individuals and/or medium term health impacts on larger (but surrounding) community and health status groups Measurable benefit to localised plant and animal communities expected to pertain to medium term. Dollar benefit in order of $50,000-$500,000, Local community and some individuals beyond immediate community receive social benefit. IV Major Significant beneficial health effects to localised community and specific groups in wider community Long term benefit to localised ecosystem(s) Dollar benefit in order of $500,000-$5,000,000 Substantial social benefit to surrounding community, and individuals in wider community. V Massive Significant long term beneficial health effects to the wider community Long term, wide spread benefits to species and/or ecosystems Dollar benefit greater than $5,000,000 Major social benefit affecting wider community Table A2.4: Calculating the level of risk Likelihood Highly Improbable Improbable Very unlikely Unlikely Likely Very likely Extremely likely 1 2 3 4 5 6 7 Minimal I A A B C D E E Magnitude of effect Minor Moderate Major II III IV A B C B C D C D E D E E E E F E F F F F F Massive V D E E F F F F The Agency considers that, for this substance, the level of risk can be assigned as follows: A Insignificant B Very low C Low D Medium E High F Extreme Environmental Risk Management Authority Decision: Application HSR06104 Page 21 of 25 Appendix 3: Environmental exposure risk assessment For Class 9 substances, the ecological risk can be assessed for a substance or its components by calculating a risk quotient based on an estimated exposure concentration. Such calculations incorporate toxicity values, exposure scenarios (including spray drift, application rates and frequencies), and the half-lives of the component(s) in soil and water. The calculations provide an Estimated Environmental Concentration (EEC) which, when divided by the LC50 or EC50, gives a risk quotient (RQ). RQ = EEC LC50 or EC50 If the RQ exceeds a predefined level of concern, this suggests that it may be appropriate to refine the risk assessment or apply/retain the AH control and/or other controls to ensure that appropriate matters are taken into account to minimise off-site movement of the substance. Conversely, if a worst-case scenario is used, and the level of concern is not exceeded, then in terms of the environment, there is a presumption of low risk which is able to be adequately managed by such things as label statements (warnings, disposal). The approved handler control can then be removed on a selective basis. Levels of concern (LOC) as proposed by the USEPA and adopted by ERMA New Zealand, to determine whether a substance poses an environmental risk are provided in Table A3.1 below. Table A3.1. Levels of Concern Endpoint Aquatic (fish, invertebrates) Acute RQ≥ Acute RQ Acute RQ< Chronic RQ≥ Plants (aquatic and terrestrial) Acute RQ≥ Mammal and birds Acute dietary RQ≥ Acute oral dose [granular products] RQ≥ Chronic RQ≥ Acute RQ = EEC/LC50 Chronic RQ = EEC/NOEC LOC Presumption 0.5 0.1-0.5 0.1 1 High acute risk Risk can be mitigated through restricted use Low risk High chronic risk 1 High acute risk 0.5 0.5 1 High acute risk High acute risk High chronic risk Assessment of Expected Environmental Concentration (EEC) – GENEEC2 The Agency has used the GENEEC2 surface water exposure model (USEPA, 2001) to estimate the EEC of 8,10-dodecadien-1-ol in surface waters which may potentially arise as a result of spray drift and surface runoff from the proposed New Zealand use pattern. The proposed maximum application rate for Checkmate CM-F is 0.183 L/ha, equivalent to 0.0257 kg ai/ha. The parameters used in the GENEEC2 modelling are listed in Table A3.2 and represent the recommended use on apples and pears which was used as a conservative estimate. Environmental Risk Management Authority Decision: Application HSR06104 Page 22 of 25 Table A3.2: GENEEC2 input parameters Application rate Application frequency Application interval Koc Aerobic soil DT50 Pesticide wetted in? Methods of application ‘No spray’ zone Water solubility Aerobic aquatic DT50 Aqueous photolysis DT50 Checkmate CM-F 0.0257 kg ai/ha 5 times per season 30 days 0.35 * kow 0.35 * 21,878 = 7,657 Not available No Air blast spray None 34.15 ppm (est) Not available 14 days Table A3.3: GENEEC2 output RUN No1 for 8,10-Dodecadien-1-ol on apples/pears * INPUT VALUES -------------------------------------------------------------------RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN) -------------------------------------------------------------------.023( .114) 5 30 7657.0 34.2 ORCHAR( 9.7) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) -------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) -------------------------------------------------------------------.00 2 N/A 14.00- 1736.00 .00 1736.00 GENERIC EECs (IN NANOGRAMS/LITER (PPTr)) Version 2.0 Aug 1, 2001 -------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC -------------------------------------------------------------------953.44 932.38 808.19 601.64 494.74 The estimated environmental concentration (EEC) of 8,10-dodecadien-1-ol as estimated by GENEEC2 = 953.44 ng/L = 0.000953 mg/L RQ = EEC LC50 or EC50 Table A3.4: Calculation of RQ Fish Crustacea Algae (Acute) EEC from GENEEC2 (mg/L) 0.000953 LC50 or EC50 (mg/L) 5.87 8.6 0.148 Environmental Risk Management Authority Decision: Application HSR06104 RQ (Acute) 0.00016 0.00011 0.0064 Page 23 of 25 When compared against the relevant risk quotients as shown in Table A3.1 the RQs derived from the GENEEC 2 modelling for 8,10-dodecadien-1-ol are all below the level of concern (LOC) for fish, crustacean and algae. These results suggest that the use of Checkmate CM-F will not pose a high acute aquatic risk based on the most sensitive tested aquatic species. As no chronic ecotoxicity data was available for 8,10-dodecadien-1-ol, no estimation was able to be made of chronic risk. However, it is noted that the available data on 8,10-dodecadien-1-ol suggests it will be readily degradable in the environment, and will not bioaccumulate. Environmental Risk Management Authority Decision: Application HSR06104 Page 24 of 25 Appendix 4: Confidential Environmental Risk Management Authority Decision: Application HSR06104 Page 25 of 25