ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 19 December 2006 Application Code HSR05048 Application Type To import or manufacture any hazardous substance under the Hazardous Substances and New Organisms Act 1996 (the Act) Applicant Waikato Regional Council PO Box 4010 Hamilton East Date Application Received 26 June 2006 Consideration Date 19 December 2006 Considered by A Committee of the Authority Purpose of the Application GARLON 360: To import a triethylamine salt of triclopyr for use as a herbicide for the control of specific aquatic problem weeds such as alligator weed (Category C). 1 Summary of decision 1.1 The application to import or manufacture Garlon 360 is approved with controls in accordance with the relevant provisions of the Act, the HSNO Regulations and the HSNO (Methodology) Order 1998 (the Methodology). 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: Garlon 360 2 Legislative criteria for the application 2.1 The application was lodged pursuant to section 28. The decision was determined in accordance with section 29, taking into account additional matters to be considered in 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. ERMA New Zealand Decision: Application HSR05048 Page 1 of 31 3 Application Process 3.1 The application was formally received on 26 June 2006. 3.2 In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public notification was made on 05 July 2006. 3.3 Submissions closed on 16 August 2006. 3.4 Various government departments (including the Ministry of Health, the Department of Labour Work Place Group and the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the New Zealand Food Safety Authority), Crown entities and interested parties, which in the opinion of the Authority would be likely to have an interest in the application, were notified of the receipt of the application (sections 53(4) and 58(1)(c), and clauses 2(2)(e) and 5) and provided with an opportunity to comment or make a public submission on the application. 3.5 The Agency prepared an Evaluation and Review Report (the E&R Report) to aid the Committee in its decision making process. The E&R Report consists of the Agency’s review of the application and available data regarding the substance and/or its constituent components. The E&R Report also contains an assessment of the potential risks the substance may pose to the environment, human health, Māori, community and economy and proposes a suite of controls suitable to manage those risks. 3.6 The Ministry of Health, the Department of Labour, and the ACVM Group were given the opportunity to comment on the E&R Report and the controls proposed therein. In response, the Ministry of Health indicated that: “Given that the product is envisaged to be aerially sprayed, measures on how to mitigate risk should be in place to ensure that public health is not compromised in the event of unforeseen circumstances.” The Committee has considered these risks, as addressed in Paragraph 9.49 of the Agency’s Evaluation and Review report. On the basis of environmental exposure modelling carried out by the Agency, the Committee has determined that bystander exposure will not exceed acceptable levels of risk. No other Government agency responded. 3.7 Two submissions were received. i. The Northland Regional Council supports the import or manufacture of Garlon 360 to control aquatic weeds and in particular alligator weed. According to the Council, alligator weed grows vigorously in the Far North and removal of the weed is the primary reason for machine clearing of drains in the region. ii. The Council also indicated that the Regional Water and Soil Plan for Northland makes the discharge of herbicides into water a permitted activity provided that: 3.7.1 the herbicide used is one approved for aquatic use by ERMA. ERMA New Zealand Decision: Application HSR05048 Page 2 of 31 3.8.2 3.8.3 3.7.4 the application is carried out by a suitably qualified person. application rates of the herbicide do not exceed those stated on the most recent product label for the relevant application equipment or method and target plant. the discharger shall notify: (i) every person taking water for domestic supply within one kilometre downstream of the proposed discharge: and (ii) every holder of a resource consent for the taking of water for water supply purposes downstream of the proposed discharge, at least one week before commencing discharge. iii. Environment Southland believes that an approval to import Garlon 360 will provide the applicant and other agencies with a necessary tool to control alligator weed and other marginal aquatic pest plants more effectively. 3.8 Two waivers were issued in order to defer the consideration so that the Committee could review additional information sought from the applicant by the Agency. These waivers covered a total period of 57 days. 3.9 The applicant was given an opportunity to comment on the proposed controls as set out in the E&R Report (clause 35(b)). Their comments were taken into account in the consideration of the application. 3.10 The following members of the Authority considered the application (section 19(2)(b)): Mr Tony Haggerty (Chair), Professor George Clark and Ms Helen Atkins. 3.11 The information available to the Committee comprised: the application, including confidential appendices; the E&R Report. 4 Consideration Purpose of the application 4.1 The purpose of the application is to gain approval to import or manufacture for release the water-based herbicide Garlon 360, containing triclopyr as the triethylamine salt, for use in controlling aquatic emergent weeds such as alligator weed and parrot’s feather. Sequence of the consideration 4.2 In accordance with clause 24, the approach adopted by the Committee was to: establish the hazard classification for the substance and derive the default controls. identify potentially non-negligible risks, costs, and benefits. assess potentially non-negligible risks, costs, and benefits in the context of the default controls and possible variations to those controls. Risks were assessed in accordance with clause 12, and costs and benefits in accordance with clause 13. ERMA New Zealand Decision: Application HSR05048 Page 3 of 31 consider and determine variations to the default controls arising from the circumstances provided for in sections 77A and 77 (3), (4) and (5) and then consolidate controls. evaluate overall risks, costs, and benefits to reach a decision. The combined impact of risks, costs and benefits was evaluated in accordance with clause 34, and the cost-effectiveness of the application of controls was considered in accordance with clause 35. Hazard classification 4.3 The Committee agreed with the hazard classification determined by the Agency and classifies the substance as follows: Garlon 360 3.1C flammable liquid 8.1A metal corrosive 6.1D acute oral toxicant 8.3A eye corrosive 6.5B contact sensitiser 6.9B target organ systemic toxicant 9.1A highly toxic to the aquatic environment 9.2A highly toxic to the soil environment 9.3C harmful to terrestrial vertebrates Default controls 4.4 The Committee considered that, in the E&R Report, the Agency correctly assigned default controls as set out in the HSNO Regulations. The default controls were used as the reference for subsequent consideration of the application; they are identified in the E&R Report (Table 8.1) and are not reproduced here. Identification of the significant risks, costs and benefits of the substance 4.5 The Committee identified potentially non-negligible risks, costs and benefits with reference to clauses 9 and 11, which incorporate relevant material from sections 2, 5, 6, and 8. Risks 4.6 The risks posed by Garlon 360 to the environment relate to its ecotoxic effects in both the aquatic and soil environments and the potential harm it may cause to terrestrial vertebrates. The Committee considers that the environmental risks are greatest during use, based on the Agency’s quantitative assessment indicating that that Garlon 360 poses a high risk to sensitive non-target aquatic plants in shallow water bodies and also to terrestrial plants. The Committee notes that Garlon 360 may pose a risk to the environment during other stages of the lifecycle, such as transport or re-packaging, if spillage occurs and is not adequately managed. ERMA New Zealand Decision: Application HSR05048 Page 4 of 31 4.7 The acute human health risks posed by Garlon 360 relate to its potential to be acutely toxic if ingested orally, as well as its potential to be corrosive to the eye and cause contact sensitisation. The Committee notes that chronic exposure to Garlon 360 may cause damage to target organs/systems, and considers that the risks associated with repeated exposure to the product are more relevant during use than during other stages of the lifecycle (particularly transport and storage when only closed containers of product are handled). 4.8 In addition to its ecotoxic and toxic hazard classifications, Garlon 360 has been classified by the Agency as flammable (3.1C – medium hazard) and corrosive to metals (8.1A). The flammability of Garlon 360 was considered throughout the lifecycle in terms of both the environmental risk and the risk to human health and safety, while the risks associated with the corrosivity of the substance were considered to be relevant in terms of their environmental impact only. 4.9 The Committee does not expect there to be any adverse impacts on the social or economic environment with the controlled use of Garlon 360. The Committee is also unaware of any likely impact Garlon 360 could have on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. The Agency has no evidence to suggest that the controlled use of Garlon 360 will breach the principles of the Treaty of Waitangi. Costs 4.10 A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. Accordingly, the costs have been assessed in an integrated fashion together with the risks in the following assessment. Benefits 4.11 A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular positive effect expressed in monetary or non-monetary terms”. Benefits that may arise from any of the matters set out in clauses 9 and 11 were considered in terms of clause 13. 4.12 The applicant has indicated that Garlon 360 would provide managers of wetland areas with a tool for managing a range of nuisance invasive weed species. The benefit of Garlon 360 is that it has strong target specificity. It is also of low risk to aquatic environments. 4.13 The major target weed species for Garlon 360 are alligator weed, parrot’s feather and willows. Research in New Zealand has demonstrated the effectiveness of triclopyr in its control of these weeds. Where glyphosate has been used, repeat applications are required for a low measure of control. New Zealand trials have demonstrated a much better level of control from triclopyr TEA salt than glyphosate at rates of 4-8 kg ae/ha. 4.14 Other weed species in riparian context of particular concern but controllable with Garlon 360 include: primrose willow (Ludwigia peploides), purple loosestrife (Lythrum salicaria), Japanese (Asiatic) knotweed (Polygonum spp.), mothplant (Araujia sercifera), old man's beard (Clematis vitalba), and climbing spindleberry (Celastrus orbiculatus). ERMA New Zealand Decision: Application HSR05048 Page 5 of 31 4.15 The applicant has indicated that control of problem aquatic weeds in drains costs around $3,000 per km where a digger is deployed for the purpose. Mechanical diggers are the most common form of drain weed control in New Zealand and cause problems such as over deepening and widening of drains and spread of fragments of weeds to new water ways. Chemical treatment is about 10 times cheaper and arguably of less impact. Non-treatment of waterways can lead to flooding and the effects from flooding can be wide-ranging and extensive. The ingress of alligator weed into some kumara growing areas adjacent to waterways has made the land less profitable and often uneconomic. 4.16 The invasive nature of alligator weed in aquatic situations poses a serious threat to the usefulness of various waterways. The benefits of control or removal of problem weeds can result in containment of spread into wetlands and swamps that would otherwise displace native ecosystems. prevention of spread of problem weeds from semi-aquatic situations to terrestrial situations on farmland that may adversely affect pasture/crop production and animal health. an improved water flow in drains and canals avoiding clogging and consequent sedimentation and flooding. Assessment of the potentially non-negligible risks and costs of the substance The risks assessed were those identified as potentially non-negligible. Risks were considered in terms of the requirements of clause 12, including the assessment of consequences and probabilities, the impact of uncertainty and the impact of risk management. In considering the risks and costs associated with Garlon 360, the Committee notes that other herbicides such as diquat and glyphosate that are registered for use near water are broad spectrum in their effects on surrounding non-target species, and that Garlon 360 is an alternative aquatic herbicide that poses less risk to non-target species. 4.17 The Committee considers that the most significant environmental risks associated with Garlon 360 are the risks to sensitive non-target plants in shallow water bodies and non-target terrestrial vegetation adjacent to aquatic areas, during the use of the substance. The Committee considers that both the risk to non-target aquatic plants and terrestrial vegetation are sufficiently mitigated by the approved handler controls and the implementation of a pending review to set Environmental Exposure Levels (EELs). The Committee considers that the environmental risks associated with all other stages of Garlon 360’s lifecycle range from insignificant to low. 4.18 The Committee considers that the most significant risk to human health and safety associated with Garlon 360 is the risk to operator health during application of the substance. Quantitative assessment of the risks to operators during both hand held and broadcast application methods have indicated a need for additional mitigation of the health risks. The Committee notes that the applicant has proposed an additional instruction to be placed on the label, specifying that operators should use goggles, chemical resistant gloves, boots and overalls when handling Garlon 360. The Committee considers that the use of this personal protective equipment will be sufficient to mitigate the risks to operators. The Committee considers that the risks ERMA New Zealand Decision: Application HSR05048 Page 6 of 31 to human health and safety during all other stages of Garlon 360’s lifecycle range form very low to low with the controls in place. Assessment of the potentially non-negligible benefits 4.19 The potentially non-negligible benefits are identified in Paragraphs 4.12 – 4.18. The Committee is unable to place an expected value on the benefits (clause 13(b)) but is satisfied that the ability of the substance to enter the market could give rise to the associated benefits. Additional controls under section 77A 4.20 Under section 77A, the Authority may impose as controls any obligations and restrictions that it thinks fit. Before imposing a control under this section, the Authority must be satisfied that, against any other specified controls that apply to the substance: (a) the proposed control is more effective in terms of its effect on the management, use and risks of the substance; or (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of the substance; or (c) the proposed control is more likely to achieve its purpose. 4.21 As Garlon 360 poses a high risk to non-target aquatic and terrestrial plants, the Committee considers that the following additional controls should be applied to Garlon 360. It is noted that these controls appear on the draft label supplied by the applicant. The Committee notes that no other such controls have been specified under the Act and, in accordance with section 77A(4)(a), is satisfied that imposing these additional controls is more effective than any other specified controls in terms of their effect on the management, use and risks of Garlon 360. The maximum application rate for aquatic emergent weeds, such as alligator weed and parrot’s feather, is 22 litres Garlon 360/ha; by surface spray, either ground-based or aerial application. Garlon 360 shall not be applied: to salt water bays or estuaries; directly to unimpounded rivers or streams; where runoff water may flow onto agricultural land; to ditches or canals used to transport irrigation water; or to drinking water, or water intakes used for human consumption. 4.22 The Committee notes that under the USA registration treated water may not be used for irrigation for 120 days or until water residue levels are determined to be less than or equal to 1ppb. The Committee considers that these restrictions should also be applied to Garlon 360 in New Zealand, and therefore has set the following control: Water treated with Garlon 360 must not be used for irrigation for 120 days or until water residue levels are determined to be less than or equal to 1ppb. ERMA New Zealand Decision: Application HSR05048 Page 7 of 31 4.23 The Committee also considers that the following control should be applied to Garlon 360 as the addition of other herbicides may reduce efficacy of triclopyr. The Committee notes that no other such control has been specified under the Act and, in accordance with section 77A(4)(a), is satisfied that imposing this additional control is more effective than any other specified control in terms of its effect on the management, use and risks of Garlon 360. Garlon 360 shall not be mixed with other herbicides when undertaking spray application over water, or in circumstances where the substance may drift onto water. 4.24 As alkylphenol ethoxylates are persistent and/or bioaccumulative, surfactants containing them should not be tank-mixed with Garlon 360 for application over water. Accordingly, the Committee sets the following control under section 77A(4) and considers that it is the effective means of managing this environmental risk: 4.25 When applied over water, Garlon 360 may only be tank-mixed with surfactants which do not contain alkylphenol ethoxylates. Regulation 36 relates to level 3 emergency management requirements. The Committee considers that, as a means of managing the risks from Garlon 360, the following additional sub-clauses are necessary. The Committee considers that these controls are relevant to this substance, and note that no other such controls have been specified under the Act. In accordance with section 77A(4)(a), the Committee is satisfied that imposing these additional controls is more effective than any other specified controls in terms of their effect on the management, use and risks of Garlon 360. The following subclauses shall 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. 4.26 The Committee also considers that additional controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances as found in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 should be applied to Garlon 360. The Committee notes that no other such controls have been specified under the Act and, in accordance with section 77A(4)(a), is satisfied that imposing these additional controls is more effective than any other specified control in terms of their effect on the management, use and risks of Garlon 360. ERMA New Zealand Decision: Application HSR05048 Page 8 of 31 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. 4.27 The Committee considers that these controls are relevant to this substance, and notes that no other such controls have been specified under the Act. In accordance with section 77A(4)(a), the Committee is satisfied that imposing these additional controls is more effective than any other specified controls in terms of their effect on the management, use and risks of Garlon 360. Variation of controls under section 77 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. 4.28 The Committee decided that the following variations to the default controls shall apply to Garlon 360. Control T1 relates to the setting of Tolerable Exposure Limits (TELs). The Committee notes that the Ministry of Health (MoH, 2000) has set a Maximum Acceptable Value (MAV) of 0.1 mg/L for triclopyr. The Committee is adopting this value as the TEL water for triclopyr (note that once in water triclopyr triethylamine, the active ingredient in Garlon 360, will dissociate to yield triclopyr and the triethylamine salt). Control T2 relates to the setting of Workplace Exposure Standards (WESs). The Agency uses WES values listed in the Workplace Exposure Standards (Effective from 2002) document (see link below) http://www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf The Committee notes that Department of Labour WES values have been set for component A but is of the view that this should not be applied to Garlon 360 due to the low concentration of this component in the substance. Control E2 relates to the setting of environmental exposure limits (EELs). The Agency is intending to review the setting of EELs under section 77B. Accordingly, the Committee is not setting EELs for triclopyr triethylamine at this time and is deleting the default EELs. Controls F2 and T7 both relate to restrictions on the carriage of substances on passenger service vehicles and thus are combined under section 77(5). ERMA New Zealand Decision: Application HSR05048 Page 9 of 31 Controls T4 and E6 both relate to requirements for equipment used to handle hazardous substances and thus are combined under section 77(5). Controls P5, P13, P14 and P15 all relate to packaging requirements and thus are combined under section 77(5). Controls D2, D4 and D5 all relate to requirements for disposal of the substance, and thus are combined under section 77(5). Controls E7, AH1 and TR1 relate to approved handler and tracking requirements. These controls are triggered by the 9.1A and 9.2A classifications of Garlon 360. As the ecological risk assessment indicates that there is potential for adverse environmental effects if the substance moves off-target, the Committee considers that it is appropriate that the approved handler control remains for the use of the substance and the controls should be varied accordingly under section 77(4)(a). The tracking control is deleted under section 77(4)(a) as the risks which may arise from the life-cycle of Garlon 360 are adequately managed by controls such as packaging, labelling, approved handler and emergency management requirements. Recommendations 4.29 The Committee recommends that, should inappropriate or accidental use, transport or disposal of Garlon 360 result in the contamination of waterways, the appropriate authorities, including the relevant iwi authorities in the region, should be notified. This action should include advising them of the contamination and the measures taken in response. Environmental user charges 4.30 The Committee considers that the application of controls to Garlon 360 will provide 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. Establishment of the approach to risk in the light of risk characteristics 4.31 Clause 33 requires the Authority, when considering applications, to have regard for the extent to which a specified set of risk characteristics exist. The intention of this provision is to provide a route for determining how cautious or risk averse the Authority should be in weighing up risks and costs against benefits. 4.32 In accordance with clause 33, the Committee has established a cautious position in weighing up risks and costs against benefits because of the high level of risk posed to non-target plants and vegetation. Overall evaluation of risks, costs and benefits 4.33 Having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and section 29, risks, costs and benefits were evaluated taking account of all ERMA New Zealand Decision: Application HSR05048 Page 10 of 31 proposed controls including default controls plus proposed variations to the controls. 4.34 Clause 34 sets out the approaches available to the Authority in evaluating the combined impact of risks, costs and benefits (i.e. weighing up risks, costs and benefits). 4.35 The Committee is satisfied that, with the controls in place, the overall risks to the environment range from insignificant to very low for all stages of the lifecycle, with the exception of use during which time the risks to non-target aquatic and terrestrial plants will be sufficiently mitigated by the approved handler controls and the additional controls relating to application of the substance. 4.36 The Committee is also satisfied that, with the controls in place, the overall risks to human health range from very low to low for all stages of the lifecycle, with the exception of the risks to operators using Garlon 360. However, the Committee is satisfied that the risks to operators during the use of the substance are sufficiently mitigated by the use of PPE as specified on the product label. 4.37 The Committee does not expect there to be any adverse impacts on the social or economic environment, or on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga with the controlled use of Garlon 360. 4.38 On the basis of the risk assessment, taking into account the approved handler requirements and additional controls set under section 77A, the Committee considers that, overall the risks and costs associated with Garlon 360 will be outweighed by the benefits offered. 5 Decision 5.1 Pursuant to section 29, the Committee has considered this application to import a hazardous substance made under section 28. 5.2 The Committee is satisfied that the default controls, as varied in Paragraphs 0 to 0, and the additional controls, imposed in Paragraphs 4.21 to 4.27, will be adequate to manage the adverse effects of the hazardous substance. 5.3 Having considered all the possible effects of the hazardous substance in accordance with section 29, pursuant to clause 27, based on consideration and analysis of the information provided, and taking into account the application of controls, the view of the Committee is that the benefits associated with the substance outweigh the risks and costs posed. 5.4 In accordance with clause 36(2)(b), the Committee records that, in reaching this conclusion, it has applied the balancing tests in section 29 and clause 27. 5.5 It has also applied the following criteria in the Methodology: clause 9 – equivalent of sections 5, 6 and 8; clause 11 – characteristics of substance; clause 12 – evaluation of assessment of risks; clause 13 – evaluation of assessment of costs and benefits; ERMA New Zealand Decision: Application HSR05048 Page 11 of 31 5.6 clause 14 – costs and benefits accruing to New Zealand clause 21 – the decision accords with the requirements and regulations; clause 22 – the evaluation of risks, costs and benefits – relevant considerations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; clause 27 – risks and costs are outweighed by benefits; clause 33 – risk characteristics; clause 34 – the aggregation and comparison of risks, costs and benefits; and clause 35 – the costs and benefits of varying the default controls. The application for importation or manufacture for release of the hazardous substance, Garlon 360 is thus approved, with controls listed in Appendix 1. Tony Haggerty Date: 19 December 2006 Chair ERMA New Zealand Approval Code: HSR007690 ERMA New Zealand Decision: Application HSR05048 Garlon 360 Page 12 of 31 Appendix 1: List of Controls that apply to Garlon 360 Note: The control explanations as listed below have been provided as guidance only and do not have legal standing. Please refer to the regulations for the requirements prescribed for each control and the modifications listed set out in section 4 of this document. Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property Controls F1 7 General test certification requirements for all class 1 to 5 substances 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 all class 1 to 5 substances See T7. F3 55 General limits on flammable substances Where Garlon 360 is present at a place for longer than 18 hours, and in a quantity that exceeds 500 L in containers greater than 5 L and 250 L in open containers, the substance must be held at a hazardous substance location or transit depot as appropriate. F5 58-59 Requirements for hazardous atmosphere zones for class 3.1 substances. There is a requirement to establish a hazardous atmosphere zone wherever Garlon 360 is present in a quantity that exceeds 100 L (closed), 25 L (decanting), 5 L (open occasionally), I L (open for continuous use). 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. F6 60-70 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 class 3.1 substances. These regulations prescribe controls to reduce the likelihood of class 3.1 flammable liquids. Controls are prescribed with the aim of covering all foreseeable circumstances in which unintended ignition could take place, and include: placing limits on the proportion of flammable vapour to air to 1 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. ERMA New Zealand Decision: Application HSR05048 Page 13 of 31 Control Code1 F11 F12 Regulation2 76 77 Explanation3 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 (e.g. 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 auto-ignition 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, e.g. 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 a class 3.1 substance under any of regulations 63(4), 65, 67 and 69 must be an approved handler for that substance, i.e. 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 flammable substances, there is a requirement to ensure that Garlon 360 does not come into contact with any incompatible substance or material. There is also a requirement that packages of incompatible substances are held separately. A list of substances and materials considered incompatible with class 2, 3 and 4 substances is provided in Table 1 of Schedule 3 (Classes 1 to 5 Controls Regulations). 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 any class 3 substance is present in a quantity that exceeds 500 L in containers greater than 5 L and 250 L in open containers and held for a period exceeding either 18 hours (for substances that do not require tracking). 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; ERMA New Zealand Decision: Application HSR05048 Page 14 of 31 Control Code1 Regulation2 F14 81 F16 83 Explanation3 establish and manage a hazardous atmosphere zone when required (as prescribed by regulation 58). Test certification requirements for facilities where class 3.1 substances are present There is a test certification requirement when Garlon 360 is present at any hazardous substance location when in a quantity that exceeds 500 L in containers greater than 5 L and 250 L in open containers. 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. Controls on transit depots where flammable substances are present Transit depots are places designed to hold Garlon 360 (in containers that remain unopened) for a period of up to three days, but for periods that are more than 18 hours. Whenever Garlon 360 is held at a transit depot in quantities exceeding the levels specified in a quantity that exceeds 500 L in containers greater than 5 L and 250 L in open containers, 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, e.g. Electricity Act 1992, HSE (Mining Underground Regulations) 1999 or Civil Aviation Rules. ERMA New Zealand Decision: Application HSR05048 Page 15 of 31 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). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and it is a substance to which people are likely to be exposed to during their lifetime; and exposure is likely to result in an appreciable toxic effect. If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns. T2 29, 30 T4, E6 7 T5 8 T7, F2 10 The Committee has set 0.1 mg/L as the TEL for triclopyr. 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. No WESs for Garlon 360 are set at this time. Requirements for equipment used to handle hazardous substances Any equipment used to handle Garlon 360 (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. Requirements for protective clothing and equipment Protective clothing/equipment must be employed when Garlon 360 are 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. Restrictions on the carriage of hazardous substances on passenger service vehicles The maximum quantity per package of Garlon 360 permitted to be carried on passenger service vehicles is 1.0 L. ERMA New Zealand Decision: Application HSR05048 Page 16 of 31 Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 E2 32-45 46-48 E5 5(2), 6 E6 7 E7 9 Limiting exposure to ecotoxic substances This control relates to the setting of environmental exposure limits (EELs). An EEL establishes the maximum concentration of an ecotoxic substance legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition). An EEL can be established by one of three means: applying the default EELs specified; adopting an established EEL; calculating an EEL from an assessment of available ecotoxicological data. No EELs for Garlon 360 are set at this time. The default EELs are deleted. 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, Regulation 9) do not apply once the substance has been applied or laid. As EELs have not been set application rates have been set under section 77A. Requirements for keeping records of use A person using Garlon 360 for the purposes of causing biocidal action must keep written records of that use if 3 kg or more of the substance is applied within 24 hours in an area where the substance is likely to enter air or water and leave the place. 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 See T4. Approved handler requirements Where Garlon 360 is being used it must be under the personal control of an approved handler at all times, or locked up. However, it 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. This control only applies to the use phase of the lifecycle. ERMA New Zealand Decision: Application HSR05048 Page 17 of 31 Control Code1 Regulation2 Explanation3 Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of hazardous substances 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 hazardous substances 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 any hazardous substance 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 any hazardous substance 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, 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 ERMA New Zealand Decision: Application HSR05048 Page 18 of 31 Control Code1 Regulation2 I2 8 I3 I5 I8 9 11 14 Explanation3 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 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. Priority identifiers for corrosive substances This requirement specifies that Garlon 360 must be prominently identified as being corrosive. In addition, information must be provided on the need to prevent access to the substance by children, unless the substance is being used in a place of work, or part of a place of work, where children will not lawfully be present. 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 ecotoxic substances This requirement specifies that Garlon 360 must be prominently identified as being ecotoxic. 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 flammable substances This requirement specifies that Garlon 360 must be prominently identified as being flammable. In addition, the following information must be provided: an indication of whether the substance is a gas, aerosol, liquid or solid; if a flammable liquid, information must be provided on its general degree of hazard (e.g. highly flammable); 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 Garlon 360 must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance (unless it is used in a place of work where the general public may not lawfully be present), and the need to restrict access to the substance by children. 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. ERMA New Zealand Decision: Application HSR05048 Page 19 of 31 Control Code1 I9 Regulation2 18 I10 19 I11 20 I13 Regulation 22 Explanation3 Secondary identifiers for all hazardous substances This control relates to detail required for Garlon 360 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 corrosive substances This control relates to the additional label detail required for corrosive substances. 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 degree and general type of corrosive hazard (e.g. highly corrosive to the skin); an indication of the circumstances in which it may harm skin or eye tissue, and the type and extent of harm it is likely to cause; an indication of the circumstances in which it damage metallic objects, and the type and extent of damage it is likely to cause; the name and concentration of Component A. Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for ecotoxic substances. 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; in the case of an ecotoxic substance of classification 9.1A, an indication of its general type and degree of hazard (e.g. very toxic to aquatic life); in the case of an ecotoxic substance of classification 9.2A, an indication of its general type of hazard (e.g. ecotoxic to terrestrial plants). Secondary identifiers for flammable substances This control relates to the additional label detail required for flammable substances. 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 (e.g. highly flammable liquid); an indication of the circumstances in which it may be ignited unintentionally; an indication of the likely effect of an unintentional ignition; ERMA New Zealand Decision: Application HSR05048 Page 20 of 31 Control Code1 Regulation2 I16 25 I17 26 Explanation3 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 toxic substances. 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 (eg mild skin irritant); 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 triclopyr triethylamine 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 19(f) and 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 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. [Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the product label, the name of any ingredient that would independently of any other ingredient, cause the substance to be classified as either 6.1A, 6.1B, 6.1C, 6.1D, 6.5, 6.6, 6.7, 6.8, 6.9, 8.2 or 8.3]. I18 I19 27 29-31 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 19(f) and 25(e) and (f). [Regulations 19(f) and 25(e) and (f) specify a requirement to list on the product label, the concentration of any ingredient that would independently of any other ingredient, cause the substance to be classified as either 6.1A, 6.1B, 6.1C, 6.1D, 6.5, 6.6, 6.7, 6.8, 6.9, 8.2 or 8.3]. 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 substances are 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 ERMA New Zealand Decision: Application HSR05048 Page 21 of 31 Control Code1 Regulation2 Explanation3 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. Regulation 30 – Substances in multiple packaging This Regulation relates to situations when hazardous substances are 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. 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 Garlon 360 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 Garlon 360 is held in the workplace in quantities equal to or greater than 1.0 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 Garlon 360 in quantities equal to or greater than 1.0 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. ERMA New Zealand Decision: Application HSR05048 Page 22 of 31 Control Code1 Regulation2 Explanation3 Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where hazardous substances are 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 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 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 Triclopyr triethylamine; Component A. 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 Garlon 360 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 0.3m. Regulation 49 – Documentation requirements for vehicles This Regulation provides for the option of complying with ERMA New Zealand Decision: Application HSR05048 Page 23 of 31 Control Code1 Regulation2 I22 40 I23 41 I25 43 I28 46 Explanation3 documentation requirements as specified in the various Land, Sea and Air transport rules when the substance is being transported. 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 corrosive substances The documentation provided with Garlon 360 must include the following information: its general degree and type of corrosive hazard (e.g. highly corrosive to the skin); a full description of the circumstances in which it may cause unintentional damage to tissue or metallic objects; a full description of the potential consequences of any damage it may cause to tissue or metallic objects; a full description of the steps to be taken to prevent unintentional damage to tissue or metallic objects; for substances of class 8.3, its pH or pH range. Specific documentation requirements for ecotoxic substances The documentation provided with Garlon 360 must include the following information: its general degree and type of ecotoxic hazard (e.g. highly ecotoxic to terrestrial vertebrates); 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; 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 Garlon 360 must include the following information: its general degree and type of 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; if it is a liquid, 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 Garlon 360 must include the following information: its general degree and type of toxic hazard; a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; ERMA New Zealand Decision: Application HSR05048 Page 24 of 31 Control Code1 Regulation2 I29 51-52 Explanation3 a full description of the steps to be taken to prevent harm to human beings; if it will be a liquid during its use, 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 hazardous Garlon 360 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. I30 53 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 (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). Advertising corrosive and toxic substances Any advertisement for Garlon 360 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 is used in a place of work where members of the public may not lawfully be present). Any advertisement for Garlon 360 must include information that identifies the substance is corrosive and indicates the need to restrict access by children (unless the substance is to be used in a place of work where children 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. ERMA New Zealand Decision: Application HSR05048 Page 25 of 31 Control Code1 Regulation2 Explanation3 Regulation 5 – Ability to retain contents Packaging for all hazardous substances 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 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 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 any hazardous substance, 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 Hazardous substances 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. “Large Packaging” does not include: P3 9 P5, P13, P14, P15 11, 19, 20, 21 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 substances packed in limited quantities When Garlon 360 is packaged in packages of 1.0 L or less, there is provision for it to be packaged to a lesser performance standard than normally required (as specified in Schedule 4 of the Packaging Regulations). Packaging requirements for Garlon 360 Garlon 360 in quantities of more than 1L must be packaged according to Schedule 3 (UN PGIII), but must be packaged according to either ERMA New Zealand Decision: Application HSR05048 Page 26 of 31 Control Code1 Regulation2 PG3 Schedule 3 PS4 Schedule 4 Explanation3 Schedule 3 or Schedule 4 when in quantities equal to or less than 2kg or 1L. Garlon 360 that is offered for sale in a package of less than 2.5L or 2.5kg must be in child resistant packaging (i.e. toxic and corrosive 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 this substance when packaged in quantities of more than 1L. The tests in Schedule 3 correlate to the packaging requirements of UN Packing Group III (UN PGIII). This schedule describes the minimum packaging requirements that must be complied with for this substance when packaged in quantities equal to or less than 1 L. Hazardous Substances (Disposal) Regulations 2001 D2, D4, D5 6, 8, 9 Disposal requirements Garlon 360 must be disposed of by: treating the substance so that it is no longer a hazardous substance. Treatment does not include depositing the substance in a landfill or sewage facility but can include controlled burning providing that the performance requirements as set out in Regulation 6(3)(b) of the Disposal Regulations for protecting people and the environment are met; or discharging the substance 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 EEL (environmental exposure limit) or TEL set by the Authority for that substance; or exporting the substance from New Zealand as a hazardous waste. D6 10 Disposal requirements for packages This control gives the disposal requirements for packages that contained Garlon 360 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 Garlon 360 that exceeds 0.1 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. 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 ERMA New Zealand Decision: Application HSR05048 Page 27 of 31 Control Code1 Regulation2 Explanation3 supplying a quantity of a Garlon 360 that exceeds 1.0 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 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 Garlon 360. 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)). EM2 8(a) 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 corrosive substances The following information must be provided with Garlon 360 when present in any quantity: a description of the usual symptoms of exposure; a description of the first aid to be given; a 24-hour emergency service telephone number. Information requirements for toxic substances The following information must be provided when Garlon 360 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 Garlon 360 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 Garlon 360 is sold or supplied, or held in a ERMA New Zealand Decision: Application HSR05048 Page 28 of 31 Control Code1 Regulation2 Explanation3 workplace, in quantities equal to or greater than 1.0 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. EM9 17 EM10 21-24 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). Specific documentation requirements for flammable substances There is an additional requirement for flammable substances 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 Garlon 360 is held in a place of work in quantities exceeding 500 L, must have the specified number of fire extinguishers (two) (Regulation 21). The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching hazardous substances, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of hazardous substances. Each fire extinguisher must be located within 30m of the substance, 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 (50mm deep and at least 6m2 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 Garlon 360 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 Garlon 360 is held in quantities equal to or greater than 100 L. Regulation 36 prescribes requirements for secondary containment ERMA New Zealand Decision: Application HSR05048 Page 29 of 31 Control Code1 Regulation2 Explanation3 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, e.g. there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to 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 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. EM13 42 Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where Garlon 360 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 Garlon 360 is 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 ERMA New Zealand Decision: Application HSR05048 Page 30 of 31 Control Code1 Regulation2 Explanation3 regulation 6 describes situations where transitional qualifications for approved handlers apply. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable applicable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notices Flammable Schedules 8, 9 The controls relating to stationary container systems, secondary Liquids and 10 DGTN containment and unintended ignition of flammable substances, as set March 2004 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. Additional controls under section 77A The maximum application rate proposed for aquatic emergent weeds, such as alligator weed and parrot’s feather, is 22 litres Garlon 360/ha; by surface spray, either ground-based or aerial application. Garlon 360 shall not be applied to salt water bays or estuaries. Garlon 360 shall not be applied to unimpounded rivers or streams. Garlon 360 shall not be applied where runoff water may flow onto agricultural land. Garlon 360 shall not be applied to ditches or canals used to transport irrigation water. Garlon 360 shall not be applied to drinking water, or water intakes used for human consumption. Water treated with Garlon 360 must not be used for irrigation for 120 days or until water residue levels are determined to be less than or equal to 1ppb. Garlon 360 shall not be tank mixed with other herbicides when undertaking spray application over water, or in circumstances where the substance may drift onto water. When applied over water, Garlon may only be tank-mixed with surfactants which do not contain alkylphenol ethoxylates. ERMA New Zealand Decision: Application HSR05048 Page 31 of 31