ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 22 March 2007 Application code: HSR07012 Application type Importation or manufacture of a hazardous substance for release under Section 28A(2)(c) the Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act) Applicant: Adria NZ Ltd Purpose of the application Nematak 400EC: to seek approval to import or manufacture as a nematicide for use in a range of crops (reduced hazard) Date application received: 22 February 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 Nematak 400EC 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 Nematak 400EC being formulated so that 1 or more of its hazardous properties has a lesser degree of hazard than a substance approved under the Act. 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: Nematak 400EC 2 Legislative criteria for application 2.1 The application was lodged pursuant to section 28.The decision was determined in accordance with section 28A(2)(c), 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 Nematak 400EC for release as an insecticide. 3.2 The application was formally received on 22 February 2007. 3.2.1 3.3 The Agricultural Compounds & Veterinary Medicines Group (ACVMG) of the New Zealand Food Safety Authority (NZFSA), the Department of Labour Workplace Group and the Department of Conservation were advised of the application (clause 2(2)(e)). 3.3.1 3.4 3.5 The application timeframe was extended by six days as the result of a request for further information under section 52. 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) Sekove Tinalevu Advisor (Hazardous Substances) Peter Dawson Principal Scientist (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 Adria NZ Ltd seeks approval, under section 28, to import or manufacture Nematak 400EC for release in New Zealand as a nematicide. 4.2 A substance can be assessed by rapid assessment procedures, under section 28A(2)(c), if it can be shown that it has been formulated so that one or more of its hazardous properties has a lesser degree of hazard than any substance already approved under the Act. 4.3 The approach adopted when considering this application was: to identify the composition and hazardous properties of the proposed substance, Nematak 400EC, and of a reference substance; to determine whether the reference substance is one that has been approved by the Authority and whether the proposed substance has been formulated so that one or more of its hazardous properties has a lesser degree of hazard than the reference substance. 4.4 And then: to determine whether the proposed substance has a similar use to the reference substance; to consider whether the risks posed by the proposed substance are the same as, less than or greater than those posed by the reference substance; to consider whether there are any other effects that mean the proposed substance should not be rapidly assessed; and to consider whether the controls that apply under the Act will adequately prevent or manage the adverse effects of the proposed substance. Environmental Risk Management Authority Decision: Application HSR07012 Page 2 of 30 Information review 4.5 The project team has reviewed the information supplied by Adria NZ 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 Nematak 400EC (clauses 29 and 30). Identification of the reference substance 4.6 The applicant identified a reference substance with which they considered Nematak 400EC may be compared. This reference substance was approved under section 28A of the Act on 10 May 2006 and given the HSNO Approval Number HSR002480. 4.7 However, as the proposed reference substance was itself approved by rapid assessment, the project team considers a more appropriate reference substance to be one that was transferred under the Act on 1 July 2004 by way of the Hazardous Substance (Pesticides) Transfer Notice 2004 under the generic substance description “Emulsifiable concentrate containing 400 g/litre fenamiphos” and given the HSNO Approval Number HSR000198, and has used it as such for this application. Composition of Nematak 400EC relative to that of the reference substance 4.8 Both Nematak 400EC and the reference substance contain the same active ingredient, fenamiphos, and are in emulsifiable concentrate form. 4.9 The active ingredient and solvents are the major hazardous components conferring the hazard classifications to Nematak 400EC.The active component and different solvents are the major hazardous components conferring the hazard classifications to the reference substance. 4.10 The concentration of the active ingredient is greater in Nematak 400EC than in the reference substance but the total concentration of major hazardous components is greater in the reference substance than in Nematak 400EC.However, the Agency considers that the levels of these differences are within acceptable limits. Hazardous properties of Nematak 400EC relative to that of the reference substance 4.11 The project team has determined the hazard profile of Nematak 400EC based on the information provided by the applicant and other available information. The hazard classifications for Nematak 400EC are set out in Table 4.1 for comparison against the reference substance. Table 4.1: Comparison of hazard classifications Hazard Endpoint Nematak 400EC Reference substance 3.1C 6.1B 6.1C 6.1D 6.3B 6.4A 3.1C 6.1B 6.1C 6.1D 6.3A 6.4A Flammability Acute Toxicity (Oral) Acute Toxicity (Dermal) Acute Toxicity (Inhalation) Skin Irritation/Corrosion Eye Irritation/Corrosion Environmental Risk Management Authority Decision: Application HSR07012 Page 3 of 30 Hazard Endpoint Reproductive/developmental toxicity Target Organ Toxicity Aquatic Ecotoxicity Soil Ecotoxicity Ecotoxicity to terrestrial vertebrates Ecotoxicity to terrestrial invertebrates Nematak 400EC Reference substance 6.9A 9.1A 9.2B 9.3A 9.4A 6.8B 6.9A 9.1A 9.2B 9.3A 9.4A 4.12 The project team notes that Nematak 400EC does not trigger the 6.8B hazard classification and has a reduced skin irritancy classification.This difference in hazard profile is due to the use of excipients in the reference substance which are not present in Nematak 400EC. Meeting the criteria for rapid assessment under section 28A(2)(c) 4.13 Based on the comparison and assessment detailed above, the project team considers that the criteria for rapid assessment under section 28A(2)(c) have been met through Nematak 400EC being formulated so that one or more of its hazardous properties has a lesser degree of hazard than a substance that has been approved under the Act. Use of the proposed substance relative to the reference substance 4.14 Nematak 400EC and the reference substance are both nematicides in emulsifiable concentrate form and intended for use in the same manner and at the same application rates. 5 Controls Default controls 5.1 Based on the hazard classifications determined for the substance, a set of associated default controls has been identified by the project team as being applicable to Nematak 400EC.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 Nematak 400EC, which are not addressed by the default controls. These are considered in Paragraph 5.5 of this document. 5.3 The project team notes that controls E4 and T8 relate to requirements for protecting terrestrial vertebrates. These controls have been triggered for Nematak 400EC on the basis of its intrinsic hazards; however, these controls are not considered relevant based on the substance’s form and use as a nematicide and therefore have not been listed. This is consistent with the reference substance. Table 5.1: List of default controls for Nematak 400EC Flammability Controls F1 General test certification requirements for hazardous substance locations F2 Restrictions on the carriage of flammable substances on passenger service vehicles F3 General limits on flammable substances F5 Requirements regarding hazardous atmosphere zones for class 2.1.1, 2.1.2 and 3.1 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. Environmental Risk Management Authority Decision: Application HSR07012 Page 4 of 30 1 substances Requirements to prevent unintended ignition of class 2.1.1, 2.1.2 and 3.1 substances Segregation of incompatible substances Requirement to establish a hazardous substance locations if flammable substances are present F14 Test certification requirements for facilities where class 2.1.1, 2.1.2 or 3.1 substances are present F16 Controls on transit depots where flammable substances are present 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. T3 Requirements for keeping records of use T4 Requirements for equipment used to handle substances T5 Requirements for protective clothing and equipment T6 Approved handler/security requirements for certain toxic 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 E3 Controls relating to protection of terrestrial invertebrates eg beneficial insects E5 Requirements for keeping records of use E6 Requirements for equipment used to handle substances E7 Approved handler/security requirements for certain ecotoxic substances Identification Controls I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability I3 Priority identifiers for ecotoxic substances I5 Priority identifiers for flammable substances I8 Priority identifiers for toxic substances I9 Secondary identifiers for all hazardous substances I11 Secondary identifiers for ecotoxic substances I13 Secondary identifiers for flammable substances I16 Secondary identifiers for toxic substances I17 Use of generic names I18 Requirements for using concentration ranges I19 Additional information requirements, including situations where substances are in multiple packaging I20 Durability of information for class 6.1 substances I21 General documentation requirements I23 Specific documentation requirements for ecotoxic substances I25 Specific documentation requirements for flammable substances I28 Specific documentation requirements for toxic substances I29 Signage requirements I30 Advertising corrosive and toxic substances 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 P5 Packaging requirements for flammable liquids P13 Packaging requirements for toxic substances P15 Packaging requirements for ecotoxic substances PG2 Packaging requirements equivalent to UN Packing Group II PG3 Packaging requirements equivalent to UN Packing Group III F6 F11 F12 Environmental Risk Management Authority Decision: Application HSR07012 Page 5 of 30 PS4 Packaging requirements as specified in Schedule 4 Disposal Controls D2 Disposal requirements for flammable substances D4 Disposal requirements for toxic and corrosive substances D5 Disposal requirements for ecotoxic substances D6 Disposal requirements for packages D7 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 EM9 Additional information requirements for flammable and oxidising substances and organic peroxides EM10 Fire extinguisher requirements 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 Tracking Controls TR1 General tracking requirements Approved Handler Controls AH1 Approved Handler requirements (including test certificate and qualification requirements) 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 5.4 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 Nematak 400EC: (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. 5.5 The following control additions have been proposed for Nematak 400EC by the project team: 5.5.1 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 Nematak 400EC as being more effective in terms of its effect on the use of the substance than the default controls: Nematak 400EC shall not be applied directly onto or into water. Environmental Risk Management Authority Decision: Application HSR07012 Page 6 of 30 5.5.2 The project team notes that the default controls do not address all the risks associated with stationary container systems, secondary containment and unintended ignition of flammable substances. 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 Nematak 400EC and proposes that the following controls should be applied to the substance: The controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances, as set out in Schedules 8, 9 and 10 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 Schedules 8 and 9 and clause 1 of Schedule 10. 5.5.3 The project team notes that the default controls do not allow for dispensation where it is unnecessary for pipework to have secondary containment. Accordingly, the project team considers that the application of controls will be more effective than the default controls in terms of their effect on the management, use and risks of the substance. 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 relating to control EM12 in order to address this risk area: (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. 5.6 The project team notes that these controls have similarly been applied to the reference substance and have been incorporated into the list of controls for Nematak 400EC detailed in Appendix 1. Variation of controls under section 77 5.7 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. Under section 77(5), where a substance triggers more than one hazard classification, controls may be combined. Environmental Risk Management Authority Decision: Application HSR07012 Page 7 of 30 5.8 The following variations have been proposed for Nematak 400EC by the project team: 5.8.1 The project team notes that the risks posed by storing this substance may be reduced in certain circumstances. Accordingly, it is considered appropriate to vary the default control F14 by adding the following to regulation 81 of the Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001, under section 77(4)(b) as the variation will not significantly increase the adverse effects of the substance.This control has similarly been varied for the reference substance: A hazardous substance location does not require a test certificate if— (a) the hazardous substance location is situated on a farm of not less than 4 hectares; and (b) the combined quantity of each class 3.1B or class 3.1C substance and any petrol, aviation gasoline, or racing gasoline stored at the location is less than 2,000 litres; and (c) either— (i) the following requirements are complied with: (A) each substance is stored in 1 or more secure containers, each of which has a capacity of less than 250 litres; and (B) each container complies with regulation 11 and Schedule 2 of the Hazardous Substances (Packaging) Regulations 2001; and (C) each container is— (1) situated not less than 15 metres from any area of high intensity land use or area of regular habitation; and (2) situated either in the open or in a well-ventilated building; and (3) in a compound or located so that any spillage of the substance will not endanger any building, or flow into any stream, lake, or natural water; or (ii) the following requirements are complied with: (A) each substance is stored in an above ground stationary tank that complies with the Stationary Container Controls in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004, as amended by this Schedule; and (B) each of the above ground stationary tanks is situated— (1) not less than 20 metres from any area of high-intensity land use or area of regular habitation; and (2) 6 metres from any combustible materials; and (3) in a compound or located so that any spillage of the substance will not endanger any building, or flow into any stream, lake, or natural water. 5.8.2 Control T1 relates to limiting exposure to toxic substances through the setting of Tolerable Exposure Limits (TELs).ERMA New Zealand is considering a range of issues relating to TELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005.The project team notes that TELs have not been set for the reference substance and therefore proposes that no TELs should be set at this time for Nematak 400EC. 5.8.3 Control T2 relates to the requirement to set Workplace Exposure Standards (WESs).Under regulation 29(2) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001, the project team proposes, as a workplace exposure standard for component D1, the value or values specified in the document described in “Workplace Exposure Standards”, published by the Occupational see the confidential Appendix 2 for a key to component identity Environmental Risk Management Authority Decision: Application HSR07012 1 Page 8 of 30 Safety and Health Service, Department of Labour, January 2002, ISBN 0-47703660-0.Also available at www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf. 5.8.4 Control E1 relates to limiting exposure to toxic substances through the setting of Environmental Exposure Limits (EELs).ERMA New Zealand is considering a range of issues relating to EELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005.The project team notes that EELs have not been set for the reference substance and therefore proposes that no EELs should be set at this time for Nematak 400EC and default EELs are deleted. 5.8.5 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. 5.8.6 The project team notes that the risks posed by handling this substance may be reduced in certain circumstances. Accordingly, it is considered appropriate to vary the default controls T6 and E7 by inserting the following clauses after regulation 9 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001, under section 77(4)(b) as the variation will not significantly increase the adverse effects of the substance.The approved handler controls for the reference substance have similarly been varied: 9A Exception to approved handler requirement for transportation of packaged pesticides (1) Regulation 9 is deemed to be complied with if— (a) when this substance is being transported on land— (i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system for the time being approved under section 6D of the Transport Services Licensing Act 1989; and (ii) other than by rail the person who drives, loads, and unloads the vehicle that is transporting the substance has a current dangerous goods endorsement on his or her driver licence; and (iii) in all cases, Land Transport Rule: Dangerous Goods 1999 (Rule 45001) is complied with; or (b) when this substance is being transported by sea, one of the following is complied with: (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A): (ii) International Maritime Dangerous Goods Code; or (c) when this substance is being transported by air, Part 92 of the Civil Aviation Rules is complied with. (2) Subclause (1)(a)— (a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 applies; but (b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations. (3) Subclause (1)(c)— (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but (b) does not apply to the handling of this substance in any place that is not within an aerodrome; Environmental Risk Management Authority Decision: Application HSR07012 Page 9 of 30 (4) In this regulation, UN Model Regulations means the 13th revised edition of the Recommendation on the transport of Dangerous Goods Model Regulations, published in 2003 by the United Nations. 5.9 5.8.7 The project team considers that controls F2 and T7 may be combined under section 77(5) as they both relate to requirements for carriage of substances on passenger service vehicles. 5.8.8 The project team considers that controls T3 and E5 may be combined under section 77(5) as they both relate to requirements for keeping records of use for Nematak 400EC. 5.8.9 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 Nematak 400EC. 5.8.10 The project team considers that controls T6 and E7 may be combined under section 77(5) as they both relate to approved handler requirements for Nematak 400EC. 5.8.11 The project team considers that controls P3, P5, P13 and P15 may be combined under section 77(5) as they all relate to packaging requirements for Nematak 400EC. 5.8.12 The project team considers that controls D2, D4 and D5 may be combined under section 77(5) as they all relate to disposal requirements for Nematak 400EC. It is noted that changes may have been made in legislation subsequent to the approval of the reference substance. These regulatory changes now also apply to the reference substance (section 77(2)(a)). 5.10 The modifications to controls, as above, have been incorporated into the list of controls for Nematak 400EC detailed in Appendix 1. 6 Assessment of the adverse effects 6.1 The project team notes that there are no substantial differences in the life cycle, use, purpose and presentations between the proposed substance and the reference substance. 6.2 The project team has not identified any new or additional risks posed by Nematak 400EC when compared with the reference substance, and the controls assigned to the reference substance are similarly applicable to Nematak 400EC. 6.3 The project team considers that there are no other matters which would prevent this application for Nematak 400EC from being rapidly assessed. 7 Environmental user charges 7.1 The project team considers that use of controls on Nematak 400EC 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 Environmental Risk Management Authority Decision: Application HSR07012 Page 10 of 30 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 Nematak 400EC, I am satisfied that the proposed substance meets the criteria for rapid assessment under section 28A(2)(c) in that it has been formulated so that one or more of its hazardous properties has a lesser degree of hazard than an approved reference substance. 8.3 Given the similarities in life cycle and use of Nematak 400EC and the reference substance, I do not expect that an increase in potential exposure will occur. As the risks posed by the proposed substance are somewhat less than that of the reference substance, I consider that applying the same suite of controls to Nematak 400EC, with the additions and amendments proposed under Paragraphs 5.5 to 5.8.12 (inclusive) will ensure adequate management of the adverse effects of Nematak 400EC. 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, Nematak 400EC, for release is thus approved with controls as detailed in Appendix 1. Rob Forlong Chief Executive, ERMA New Zealand Nematak 400EC ERMA New Zealand Approval Code: Environmental Risk Management Authority Decision: Application HSR07012 Date: 22 March 2007 HSR007769 Page 11 of 30 Appendix 1: controls applying to Nematak 400EC The controls imposed on Nematak 400EC 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. Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - flammable Property Controls F1 7 General test certification requirements for Nematak 400EC Where a test certificate is required for a hazardous substance location holding flammable substances, that test certificate must be issued by an approved test certifier and must typically be renewed yearly. However, the Authority can, on request by the persons required to obtain the test certificate, extend the time period to three years. F2 8 General public transportation restrictions and requirements for Nematak 400EC T7 10 The maximum quantity per package of Nematak 400EC permitted to be Classes 6,8 and 9 carried on passenger service vehicles is 0.1 L. control regulations F3 55 F5 58-59 F6 60-70 General limits on flammable substances Where Nematak 400EC is present at a place for longer than 18 hours, and in a quantity that exceeds the levels as below, that substance must be held at a hazardous substance location or transit depot as appropriate: closed containers: 500 L in containers greater than 5 L 1,500 L in containers up to and including 5 L open containers: 250 L Requirements for hazardous atmosphere zones for Nematak 400EC There is a requirement to establish a hazardous atmosphere zone wherever Nematak 400EC is present in quantities greater than those specified below. The zone must comply with either of the AS/NZS Standards as listed in Regulation 58(a)-(b) or with an ERMA approved code of practice: 100 L (closed) 25 L (decanting) 5L (open occasionally) 1L (if in open container for continuous use) Regulation 59 discusses the application of other legislation with respect to electrical systems located within a hazardous atmosphere zone. Specifically, any controls placed on electrical systems or electrical equipment within a hazardous atmosphere zone must be consistent with any controls on such systems/equipment set under other legislation if they are relevant to that specific location. This is to ensure that any potential ignition sources from electrical system or electrical equipment are protected or insulated to an extent that is consistent with the degree of hazard. Requirements to reduce the likelihood of unintended ignition of Nematak 400EC These regulations prescribe controls to reduce the likelihood of unintended ignition of Nematak 400EC.Controls are prescribed with the aim of covering all foreseeable circumstances in which unintended ignition could take place, 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 HSR07012 Page 12 of 30 Control Code1 F11 F12 Regulation2 76 77 Explanation3 and include: placing limits on the proportion of flammable vapour to air to ensure that the proportion of flammable vapour to air will always be sufficiently outside the flammable range, so that ignition cannot take place; and ensuring that there is insufficient energy available for ignition. This energy could be in the form of either temperature or ignition energy (eg a spark).Accordingly, the controls provide two approaches to ensure that there is insufficient energy for ignition: (1) keeping the temperature of the substance, or the temperature of any surface in contact with the substance, below 80% of the autoignition temperature of the substance, and (2) keeping sources of ignition below the minimum ignition energy, either by removal of the ignition source from any location where flammable substances are handled, or by protecting the “general” mass of flammable material from the ignition source, eg by enclosing any ignition sources in an enclosure that will not allow the propagation of the flame to the outside; or using flameproof motors especially designed to prevent ignition energy escaping. It should be noted that any person handling any quantity of Nematak 400EC under any of regulations 63(4), 65, 67 and 69 must be an approved handler for that substance, ie the trigger quantities that typically activate approved handler requirements do not apply [Regulation 60(2)]. Segregation of incompatible substances In order to reduce the likelihood of unintended ignition of Nematak 400EC, there is a requirement to ensure that it does not come into contact with any incompatible substance as below. There is also a requirement that packages of incompatible substances are held separately: all class 1 substances all class 2 substances class 3.2 substances all class 4 substances all class 5 substances This regulation does not apply to substances that are located on a vehicle, ship or aircraft if they are segregated in accordance with the Land Transport Rules, the Maritime Rules or the Civil Aviation Rules as relevant. Requirement to establish a hazardous substance location if flammable substances are present There is a requirement to establish a hazardous substance location where Nematak 400EC is present in quantities greater than those specified below and held for a period exceeding 18 hours: closed containers: 500 L in containers greater than 5 L 1,500 L in containers up to and including 5 L open containers: 250 L Within such zones, there is a requirement for the person in charge to: notify the responsible enforcement authority of the locality and capacity of the hazardous substance location; where relevant, ensure that the substances will be under the control of an approved handler and that the requirements of regulation 56 are met; ensure that any location test certification requirements are met; ensure that a site plan is available for inspection; establish and manage a hazardous atmosphere zone when required (as prescribed by regulation 58). Environmental Risk Management Authority Decision: Application HSR07012 Page 13 of 30 Control Code1 F14 Regulation2 81 Explanation3 Test certification requirements for facilities where Nematak 400EC is present There is a test certification requirement when Nematak 400EC is present at any hazardous substance location when in quantities as follows: closed containers: 500 L in containers greater than 5 L 1,500 L in containers up to and including 5 L open containers: 250 L That test certificate must be issued by an approved test certifier and must demonstrate compliance with a number of specified controls, including: ensuring that the responsible enforcement authority has been notified of the locality and capacity of the hazardous substance location; approved handler requirements; security requirements; hazardous atmosphere zone requirements, including controls on electrical systems and electrical equipment; segregation of incompatible substances; signage requirements; emergency management requirements, including fire-fighting equipment, emergency response plans and secondary containment; ensuring that a site plan is available for inspection. Control F14 is varied as follows: A hazardous substance location does not require a test certificate if— (a) the hazardous substance location is situated on a farm of not less than 4 hectares; and (b) the combined quantity of each class 3.1B or class 3.1C substance and any petrol, aviation gasoline, or racing gasoline stored at the location is less than 2,000 litres; and (c) either— (i) the following requirements are complied with: (A) each substance is stored in 1 or more secure containers, each of which has a capacity of less than 250 litres; and (B) each container complies with regulation 11 and Schedule 2 of the Hazardous Substances (Packaging) Regulations 2001; and (C) each container is— (1) situated not less than 15 metres from any area of high intensity land use or area of regular habitation; and (2) situated either in the open or in a well-ventilated building; and (3) in a compound or located so that any spillage of the substance will not endanger any building, or flow into any stream, lake, or natural water; or (ii) the following requirements are complied with: (A) each substance is stored in an above ground stationary tank that complies with the Stationary Container Controls in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004, as amended by this Schedule; and (B) each of the above ground stationary tanks is situated— (1) not less than 20 metres from any area of highintensity land use or area of regular habitation; and (2) 6 metres from any combustible materials; and Environmental Risk Management Authority Decision: Application HSR07012 Page 14 of 30 Control Code1 Regulation2 Explanation3 F16 83 Controls on transit depots where flammable substances are present Transit depots are places designed to hold hazardous substances (in containers that remain unopened) for a period of up to three days, but for periods that are more than 18 hours. (3) in a compound or located so that any spillage of the substance will not endanger any building, or flow into any stream, lake, or natural water. Whenever Nematak 400EC is held at a transit depot in quantities exceeding these levels: closed containers: 500 L in containers greater than 5 L 1,500 L in containers up to and including 5 L open containers: 250 L there is a requirement for the person in charge to: notify the responsible enforcement authority of the locality and capacity of the hazardous substance location; where relevant, ensure that the substances will be under the control of an approved handler; ensure that any road vehicle loaded with containers of class 2, 3 or 4 substances is not less than 3 m from any other vehicle or container containing compatible hazardous substances, and not less than 5 m from any other vehicle or container containing incompatible hazardous substances; ensure that containers of class 2, 3 or 4 substances held in the transit depot (but not loaded onto a vehicle) are not less than 5 m from containers of incompatible substances; ensure that all class 2, 3 or 4 substances remain in their containers and the containers remain closed; ensure the safety of any electrical equipment; comply with any signage requirements; comply with relevant parts of other Acts and Regulations, eg Electricity Act 1992, HSE (Mining Underground Regulations) 1999 or Civil Aviation Rules. 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 ADE or TEL values are set for Nematak 400EC at this time. T2 29, 30 Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. OSH WES values have been adopted for component D in Nematak 400EC. T3, E5 5(1), 5(2), 6 Requirements for keeping records of use A person using Nematak 400EC for the purposes of causing biocidal action must keep written records of each use if the application is in an area where members of the public may be present, or where the substance is likely to enter air or water and leave the place. Environmental Risk Management Authority Decision: Application HSR07012 Page 15 of 30 Control Code1 Regulation2 T4, E6 7 T5 8 T6, E7 9 Explanation3 The information to be provided in the record is described in Regulation 6(1).The record must be kept for a minimum of three years following the use and must be made available to an enforcement officer on request. Requirements for equipment used to handle hazardous substances Any equipment used to handle Nematak 400EC (eg spray equipment) must retain and/or dispense the substance in the manner intended, ie without leakage, and must be accompanied by sufficient information so that this can be achieved. Requirements for protective clothing and equipment Protective clothing/equipment must be employed when Nematak 400EC is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with the substance and is not directly exposed to a concentration of the substances that is greater than the WES for that substance. The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing/equipment may be used, and the requirements for maintaining the clothing/equipment. Approved handler requirements Where Nematak 400EC is held or used in any quantity, it must generally be under the personal control of an approved handler or locked up. However, such substances may be handled by a person who is not an approved handler if: an approved handler is present at the facility where the substance is being handled; and the approved handler has provided guidance to the person in respect of handling; and the approved handler is available at all times to provide assistance if necessary. Controls T6 and E7 are varied as follows: 9A Exception to approved handler requirement for transportation of packaged pesticides (1) Regulation 9 is deemed to be complied with if— (a) when this substance is being transported on land— (i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system for the time being approved under section 6D of the Transport Services Licensing Act 1989; and (ii) other than by rail the person who drives, loads, and unloads the vehicle that is transporting the substance has a current dangerous goods endorsement on his or her driver licence; and (iii) in all cases, Land Transport Rule: Dangerous Goods 1999 (Rule 45001) is complied with; or (b) when this substance is being transported by sea, one of the following is complied with: (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A): (ii) International Maritime Dangerous Goods Code; or (c) when this substance is being transported by air, Part 92 of the Civil Aviation Rules is complied with. (2) Subclause (1)(a)— Environmental Risk Management Authority Decision: Application HSR07012 Page 16 of 30 Control Code1 Regulation2 Explanation3 (a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 applies; but (b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations. (3) Subclause (1)(c)— (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but (b) does not apply to the handling of this substance in any place that is not within an aerodrome; (4) In this regulation, UN Model Regulations means the 13th revised edition of the Recommendation on the transport of Dangerous Goods Model Regulations, published in 2003 by the United Nations. 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 Nematak 400EC at this time and default EELs are deleted. E2 46-48 Restrictions on use within application area These Regulations relate to controls on application areas. No application rates are set for Nematak 400EC at this time. E3 49 Controls relating to protection of terrestrial invertebrates eg beneficial insects This Regulation applies to Nematak 400EC and prescribes controls to restrict the use of it in situations where they may pose a high risk to beneficial invertebrates eg honeybees. Specifically, a person must not apply Nematak 400EC: in an area where bees are foraging and the substance is in a form in which bees are likely to be exposed to it; or on specific plants likely to be visited by bees if the plant is in open flower or part bloom, or is likely to flower within a specified period of time following application of the substance (not longer than 10 days). Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of Nematak 400EC 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 Nematak 400EC 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)) Environmental Risk Management Authority Decision: Application HSR07012 Page 17 of 30 Control Code1 Regulation2 Explanation3 Regulation 6 – Identification duties of suppliers Suppliers of Nematak 400EC 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 the substance 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 the substance (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 Nematak 400EC 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 the substance 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, eg on the label. All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, eg on the label. I3 9 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; 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 ie 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. Priority identifiers for ecotoxic substances This requirement specifies that Nematak 400EC must be prominently identified as being ecotoxic. This information must be available to any person handling Nematak 400EC within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Environmental Risk Management Authority Decision: Application HSR07012 Page 18 of 30 I5 I8 11 14 I9 18 I11 20 I13 Regulation 22 Priority identifiers for flammable substances This requirement specifies that Nematak 400EC must be prominently identified as being flammable. In addition, the following information must be provided: an indication that Nematak 400EC is a liquid; information must be provided on its general degree of hazard (ie flammable liquids: medium hazard). This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for certain toxic substances This requirement specifies that Nematak 400EC must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of Nematak 400EC and the need to restrict access to the substance by children. This information must be available to any person handling Nematak 400EC within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Secondary identifiers for all hazardous substances This control relates to detail required for Nematak 400EC 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 Nematak 400EC.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 very ecotoxic in the aquatic environment, ecotoxic in the soil environment, very ecotoxic to terrestrial vertebrates, very ecotoxic to terrestrial invertebrates). Secondary identifiers for flammable substances This control relates to the additional label detail required for Nematak 400EC.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 flammable hazard (ie flammable liquids: medium hazard); an indication of the circumstances in which it may be ignited Environmental Risk Management Authority Decision: Application HSR07012 Page 19 of 30 I16 25 I17 26 unintentionally; an indication of the likely effect of an unintentional ignition; an indication of the steps to be taken to prevent an unintentional ignition. Secondary identifiers for toxic substances This control relates to the additional label detail required for Nematak 400EC.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 acutely toxic, irritating to the skin, irritating to the eye, toxic to human target organs or systems); 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; the name and concentration of fenamiphos. Use of Generic Names This control provides the option of using a generic name to identify groups of ingredients where such ingredients are required to be listed on the product label as specified by Regulations 25 (e) and (f). A generic name may also be used to identify a specific ingredient required by Regulation 25(f) to be identified, if section 55 or section 57 of the Act applies (withholding information on confidentiality grounds). The generic name must identify the key chemical entities and functional groups in the ingredients that contribute to their hazardous properties. I18 I19 27 29-31 [Regulations 25 (e) and (f) specify a requirement to list on the product label, the name of fenamiphos]. Use of Concentration Ranges This control provides the option of providing concentration ranges for those ingredients whose concentrations are required to be stated on the product label as specified by Regulations 25(e) and (f). [Regulations 25(e) and (f) specify a requirement to list on the product label, the concentration of fenamiphos]. 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 Nematak 400EC is contained in fixed bulk containers or bulk transport containers. 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. When class 1, 2, 3, 4 or 5 substances are contained, there is an additional requirement that information must be provided describing any steps to be taken to prevent an unintentional explosion, ignition combustion, acceleration of fire or thermal decomposition. 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. Environmental Risk Management Authority Decision: Application HSR07012 Page 20 of 30 Regulation 30 – Substances in multiple packaging This Regulation relates to situations when Nematak 400EC 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 ie 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. I20 36(8) I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for a hazardous substance 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. Durability of information for class 6.1 substances Any packaging in direct contact with Nematak 400EC must be permanently identified as having contained a toxic substance, unless the substance as packaged is restricted to a place of work. 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 Nematak 400EC is held in the workplace in any quantity. 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 any quantity of Nematak 400EC, 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 Nematak 400EC 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 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 Nematak 400EC must include the Environmental Risk Management Authority Decision: Application HSR07012 Page 21 of 30 following information: the unequivocal identity of the substance (eg 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 substance’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; the name, concentration and CAS number of fenamiphos. Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (eg 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 the substance 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. I23 41 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 a hazardous substance is present) if asked to do so by that person. Specific documentation requirements for ecotoxic substances The documentation provided with Nematak 400EC must include the following information: its general degree and type of ecotoxic hazard (ie very ecotoxic in the aquatic environment, ecotoxic in the soil environment, very ecotoxic to terrestrial vertebrates, very ecotoxic to terrestrial invertebrates); a full description of the circumstances in which it may harm living organisms and the extent of that harm; a full description of the steps to be taken to prevent harm to living organisms; a summary of the available acute and chronic (ecotox) data used to define the (ecotox) subclass or subclasses in which it is classified; Environmental Risk Management Authority Decision: Application HSR07012 Page 22 of 30 I25 43 I28 46 I29 51-52 its bio-concentration factor or octanol-water partition coefficient; its expected soil or water degradation rate; any EELs set by the Authority. Specific documentation requirements for flammable substances The documentation provided with Nematak 400EC must include the following information: its general degree and type of hazard (ie flammable liquids: medium hazard); a full description of the circumstances in which it may be ignited unintentionally; the likely effect of an unintentional ignition; a full description of the steps to be taken to prevent an unintentional ignition; its lower and upper explosive limits, expressed as volume percentages in air or its flash point (and flash point methodology) and auto-ignition temperature. Specific documentation requirements for toxic substances The documentation provided with Nematak 400EC must include the following information: its general degree and type of toxic hazard (ie acutely toxic, irritating to the skin, irritating to the eye, toxic to human target organs or systems); a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; 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 Nematak 400EC is held in quantities exceeding 100 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are 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 flammable liquids: medium hazard, acutely toxic, irritating to the skin, irritating to the eye, toxic to human target organs or systems, very Environmental Risk Management Authority Decision: Application HSR07012 Page 23 of 30 ecotoxic in the aquatic environment, ecotoxic in the soil environment, very ecotoxic to terrestrial vertebrates, very ecotoxic to terrestrial invertebrates); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (eg a 'No Smoking' warning near flammable substances). I30 53 Advertising Nematak 400EC Any advertisement for Nematak 400EC must include information that identifies the substance is toxic and indicates the need to restrict access by children. In addition, it must specify the general degree and type of hazard (unless it used in a place of work where members of the public may not lawfully be present). 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 Nematak 400EC 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 the substance 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 Nematak 400EC must not be marked in accordance with the UN Model Regulations unless: the markings comply with the relevant provisions of that document; and the packaging complies with the tests set out in Schedule 1, 2 or 3 (Packaging Regulations) respectively; and the design of the packaging has been test certified as complying with those tests. Regulation 7(1) – Requirements when packing hazardous substance When packing Nematak 400EC, 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 Nematak 400EC 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 Nematak 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. “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Environmental Risk Management Authority Decision: Application HSR07012 Page 24 of 30 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 Nematak 400EC Nematak 400EC in quantities over 0.1 L must be packaged according to Schedule 2 (UN PGII), but must be packaged according to Schedule 2 or Schedule 4 when in quantities equal to or less than 0.1 L P3, P5, P13, P15 9, 11, 19, 21 Nematak 400EC that is offered for sale in a package of less than 2.5 L must be in child resistant packaging (ie 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. PG2 Schedule 2 This schedule describes the (minimum) packaging requirements that must be complied with for this substance when packaged in quantities of more than 0.1 L. The tests in Schedule 2 correlate to the packaging requirements of UN Packing Group II (UN PGII). PS4 Schedule 4 This schedule describes the minimum packaging requirements that must be complied with for this substance when packaged in quantities equal to or less than 0.1 L. Hazardous Substances (Disposal) Regulations 2001 D2, D4, 6, 8, 9 Disposal requirements for Nematak 400EC D5 As provided by section 77(5), the disposal requirements for Nematak 400EC have been combined. These substances must be disposed of by: treating the substance so that it is no longer a hazardous substance; exporting the substance from New Zealand as a hazardous waste; treatment can include controlled burning providing the performance requirements as set out in regulation 6 (3)(b) of the Disposal Regulations for protecting people and the environment are met, and the burning operation does not exceed any TELs or EELs; treatment includes discharge into the environment as waste, or depositing in a landfill, provided the discharge location is managed so that: - the substance will not at any time come into contact with any substances with explosive or oxidising properties, and - there is no ignition source in the vicinity of the disposal site, and - in the event of an accidental fire, harm to people or the environment does not occur – the performance requirements for this are set out in regulation 6 (3)(b) of the Disposal Regulations, and - after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone does not exceed the TELs or EELs set by the Authority for that substance. However, this does not include dilution of the substance with any other substance prior to discharge to the environment. D6 10 D7 11, 12 Disposal requirements for packages This control gives the disposal requirements for packages that contained Nematak 400EC 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. 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 any quantity of Nematak 400EC. Environmental Risk Management Authority Decision: Application HSR07012 Page 25 of 30 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 ie that would not comply with the Disposal Regulations. Such information must be accessible to a person handling the substance 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 any quantity of Nematak 400EC. 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 the substance 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 Nematak 400EC when present in any quantity. 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 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 Nematak 400EC is present in any quantity: 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 Nematak 400EC when present in quantities equal to or greater than 0.1 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 the substance 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 Nematak 400EC is sold or supplied, or held in a workplace, in any quantity. 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 Environmental Risk Management Authority Decision: Application HSR07012 Page 26 of 30 rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM9 17 EM10 21-24 EM11 EM12 25-34 35-41 Regulation 18 prescribes location and presentation requirements for the documentation, ie 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). Specific documentation requirements for Nematak 400EC There is an additional requirement for Nematak 400EC that a description be provided of the steps to be taken to control any fire involving the substance, including the types of extinguishant to be used. Fire extinguishers Every place (including vehicles) where Nematak 400EC is held in a place of work in quantities exceeding 500 L must have two fire extinguishers. The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching Nematak 400EC, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of hazardous substances. Each fire extinguisher must be located within 30 m of Nematak 400EC or in a transportation situation, in or on the vehicle (Regulation 22).The performance measure for an extinguisher is that it must be capable of extinguishing a fully ignited pool of flammable liquid (50 mm deep and at least 6 m2 in area), before the extinguisher is exhausted, and when used by one person (Regulation 23). 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 Nematak 400EC is held (or reasonably likely to be held on occasion) in quantities greater than 100 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 Nematak 400EC is held in quantities equal to or greater than 100 L. 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, eg there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to Environmental Risk Management Authority Decision: Application HSR07012 Page 27 of 30 exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained. 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 Nematak 400EC is held at quantities equal to or greater than 100 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 (Personnel Qualification) Regulations 2001 AH1 4-6 Approved Handler requirements Some (highly) hazardous substances are required to be under the control of an approved handler during specified parts of the lifecycle. An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances. Regulation 4 describes the test certification requirements, regulation 5 describes the qualification (competency and skill) requirements and regulation 6 describes situations where transitional qualifications for approved handlers apply. see controls F2/T7 Hazardous Substances (Tracking) Regulations 2001 TR1 4(1), 5, 6 General tracking requirements Nematak 400EC is subject to tracking requirements, ie the location and movement of the substance must be recorded at each stage of its lifecycle until its final disposal. The person in charge of the place where the tracked substance is kept is responsible for ensuring that the necessary information is included in the record. This information to be provided is specified in Schedule 2 of the Tracking Regulations, and includes information on the identification of the approved handler, and on the identification, quantity, location and disposal of the substance. The record must meet the location and presentation requirements specified in Part 2 of the Identification Regulations, ie it must be accessible within 10 minutes and meet the performance standards for comprehensibility and clarity [Regulation 5(1) and (2)]. If a tracked substance is transferred to another place, the person in charge Environmental Risk Management Authority Decision: Application HSR07012 Page 28 of 30 must ensure that the record is retained for a period of 12 months. If the substance has undergone treatment that results in it no longer being a tracked substance, or if it has been intentionally or unintentionally disposed of, the record must be kept for 3 years. However these requirements do not apply to places that are vehicles. [Regulation 5(3) and (4)]. Regulation 6 prescribes requirements relating to the transfer of tracked substances from one place to another. Specifically, the person in charge may only transfer the tracked substance to another place if they have received confirmation that: an approved handler is present at the place receiving the substance; the place receiving the substance meets any location test certification requirements; any place where the substance is to be held during transit complies with the relevant requirements of the Hazardous Substances (Emergency Management) Regulations and Hazardous Substances (Classes 1 to 5 Controls) Regulations. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable Containers) 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 Nematak 400EC shall not be applied directly onto or into water The controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances, as set out in Schedules 8, 9 and 10 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 Schedules 8 and 9 and clause 1 of Schedule 10. EM12: see the control explanation for additional subclauses. Environmental Risk Management Authority Decision: Application HSR07012 Page 29 of 30 Appendix 2: Confidential Information Environmental Risk Management Authority Decision: Application HSR07012 Page 30 of 30