ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 30 August 2005 Application Code HSR04025 Application Type To import or manufacture any hazardous substance under Section 28 of the Hazardous Substances and New Organisms (HSNO) Act 1996 Applicant Dow AgroSciences Date Application Received 12 August 2004 Hearing Date 11 August 2005 Consideration Date 11 August 2005 Considered by The Hazardous Substances Standing Committee of the Authority Purpose of the Application To import or manufacture substances containing aminopyralid, for use as herbicides to control weeds in pastures. The substances are identified as GF-389, GF871, GF-982, GF-1118 and GF-1397. 1 Summary of Decision 1.1 The application to import or manufacture substances containing aminopyralid is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology). 1.2 The substances have been given the following unique identifiers for the ERMA New Zealand Hazardous Substance Register: Aminopyralid GF-389 GF-871 GF-982 GF-1118 GF-1397. 1.3 ERMA New Zealand has adopted the European Union use classification system as the basis for recording the nature and uses of substances approved. The following use categories are recorded for these substances: Main Category: 4 Wide dispersive use Industrial category: 1 Agricultural industry Function/Use category: 38 Pesticides 2 Legislative Criteria for Application 2.1 The application was lodged pursuant to section 28 of the HSNO Act. The decision was determined in accordance with section 29, taking into account additional matters to be considered in that section and matters relevant to the purpose of the HSNO Act, as specified under Part II of the HSNO Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the HSNO Act. 2.2 Consideration of the application followed the relevant provisions of the Methodology. Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology. 3 Application Process 3.1 The application was formally received on 12 August 2004. 3.2 Various government departments (including the Ministry of Health and the Department of Labour (Occupational Safety and Health), and the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines Group)), 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. 3.3 A response was received from the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines Group) stating that, “As this application will be considered under the ACVM Act, any issues which may arise under the Acts administered by MAF/NZFSA will be considered as part of that application.” 3.4 The Ministry for the Environment (MfE) indicated that the Ministry is supporting an application to reassess clopyralid by the New Zealand Business Council for Sustainable Development. As it is possible that aminopyralid will have similar effects to clopyralid on compost the Ministry suggested that controls should be applied to minimise the risk of contamination of compost via contaminated turf. 3.5 In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, the application was publicly notified on the ERMA New Zealand web site on 25 November 2004 and advertised in The Dominion Post, the New Zealand Herald, the Christchurch Press and the Otago Daily Times (section 53). 3.6 Submissions closed on 3 February 2005. ERMA New Zealand Decision: Application HSR04025 Page 2 of 50 3.7 A submission was received from Mr George Fietje of Living Earth Limited. Mr Fietje submitted that: “Clopyralid based herbicides are a threat to greenwaste recycling owing to persistence in compost.” He indicated that the NZ Business Council for Sustainable Development (NZBCSD) is, on behalf of MfE, local authorities and the composting industry, in the process of making an application to ERMA New Zealand to restrict the use of this herbicide. Mr Fietje asked that “All controls imposed on this product must be consistent with the application by NZBCSD.” 3.8 At the request of the submitter, a public hearing was held on 11 August 2005 at ERMA New Zealand’s offices in Wellington. Public notification of the hearing was published on the ERMA New Zealand website from 28 July 2005. 3.9 The following members of the Hazardous Substances Standing Committee heard and considered the application (section 19(2)(b)): Mr Tony Haggerty (Chairperson), Professor George Clark and Dr Max Suckling. 3.10 At the hearing the applicant was represented by Mr Gus Hazel of Baldwins, and Mr Colin Sharpe, Mr Peter Dryden and Mr Brian Husband of Dow AgroSciences. The submitter was represented by Mr George Fietje, Living Earth Ltd and Mr Michael Lord, Perry Environmental Ltd. 3.11 The information available to the Committee for the consideration of this application comprised: The application including confidential appendices. The ERMA New Zealand Evaluation and Review Report (E&R Report) including a confidential appendix A memo from the Agency on amendments to the E&R Report Minutes of the Pre-Hearing meeting held on 14 June 2005 Submissions and evidence presented by the applicant Submissions and evidence presented by the submitter. 3.12 No external experts were used in the consideration of this application (clause 17). 4 Consideration Purpose of the Application 4.1 The pupose of the application is to obtain approval to import aminopyralid and to import or manufacture substances containing aminopyralid for use as herbicides to control weeds in pastures and for export. 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 HSR04025 Page 3 of 50 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 costeffectiveness of the application of controls was considered in accordance with clause 35. Hazard Classification 4.3 The Committee agreed with the hazard classifications determined by the Agency and classifies the substances as follows: Aminopyralid GF-871 GF-1397 GF-389 GF-1118 GF-982 8.3A; 9.1C; 9.2A 9.1C; 9.2 A 9.2A 9.1C; 9.2A 9.1C; 9.2A 3.1D; 6.1E; 6.3B; 8.3A; 9.1B; 9.2A Default Controls 4.4 The Committee considered that the E&R Report 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 1, section 8) and are not reproduced here. Risk Assessment 4.5 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. 4.6 The evidence comprised that provided by the applicant and the submitter and additional evidence set out in the E&R Report. The scientific evidence was considered in terms of clause 25(1). 4.7 In assessing risk, the Committee gave particular consideration to risks arising from the significant hazards of the substances, i.e. ecotoxicity, human health effects and flammability. The Committee also considered the possible effects on compost of contaminated organic matter entering the compost stream and examined the extent to which exposure to hazard could be mitigated by controls (clauses 11 and 12). 4.8 Costs were considered in terms of clause 13 of the Methodology. A “cost” is defined in clause 2 as “the value of a particular adverse effect expressed in monetary or nonmonetary terms”. Therefore, these have been assessed in an integrated fashion together with the risks of those adverse effects in the following assessment. ERMA New Zealand Decision: Application HSR04025 Page 4 of 50 Potentially Significant Risks 4.9 The Committee identified potentially significant risks, costs and benefits with reference to clauses 9 and 11, which incorporate relevant material from sections 2, 5, 6, and 8. These risks are assessed below. Human Health and Safety 4.10 Only aminopyralid and GF-982, the export-only substance, have hazardous properties that exceed the HSNO human toxicity thresholds. 4.11 For an adverse effect to occur to human health the substances would need to be splashed into the eyes or onto the skin. Acute effects could occur at any stage throughout the life cycles of the substances. 4.12 Manufacture and Repacking –Workers may be exposed to aminopyralid and GF-982 during manufacture or packaging. However, with the controls in place, specifically those requiring the use of protective clothing and equipment, the level of risk has been assessed as insignificant to low. 4.13 Transportation – Accidental spillage may occur during transport between the point of import or export and the factory. Drivers and emergency workers attending a spill should be wearing appropriate protective clothing and be trained in emergency management procedures. Accordingly, with the applicable HSNO controls are in place, the level of risk has been assessed as insignificant to low. 4.14 Storage –It is highly improbable that an adverse effect will occur during storage in commercial premises when the applicable HSNO controls are in place. However, as the magnitude of effects if people are exposed range from minimal to major, the level of risk has been assessed as insignificant to low. 4.15 GF-982 is classified as a flammable liquid. An incident could occur during manufacture, transportation or storage, resulting in the release of the substance with subsequent exposure to an ignition source. GF-982 will be manufactured in purpose-built equipment and care will need to be taken to eliminate sources of ignition, and equipment used will need to be spark proof and earthed. Considering the controls in place, and recognising the relatively high flashpoint of the substance, the Committee considers the level of risk of adverse effects on human health to be very low to low. 4.16 Overall the level of risk to human health and safety arising from the use in manufacture of aminopyralid and the manufacture of GF-982 for export is considered by the Committee to be insignificant to low with the HSNO controls in place. Environmental risks 4.17 Potential significant risks to the biological and physical environment are those that involve exposure to the aquatic or terrestrial environment and those that involve potential ignition. ERMA New Zealand Decision: Application HSR04025 Page 5 of 50 4.18 Transport, storage, manufacture, packaging. An incident during manufacture, packaging, transportation, or storage resulting in the release of the substances may result in exposure to the aquatic or terrestrial environment. With adherence to the HSNO controls, including the Hazardous Substances (Packaging) Regulations 2001, and the Hazardous Substances (Emergency Management) Regulations 2001, the level of risk associated with manufacture, packaging, storage and transportation of the aminopyralid substances is assessed as insignificant to very low. 4.19 Use of spray - spillage. There is potential for spillage resulting in environmental contamination during the mixing operation (opening container, measuring out the required quantity, and pouring that into the spray tank). With the HSNO controls, label directions and SDS information in place and with adherence to the Code of Practice for the Management of Agrichemicals NZS8409:2004, level of risk is assessed as insignificant to very low. 4.20 Use of spray - spray drift onto terrestrial plants. There is a high acute risk to nontarget terrestrial plants from off-site movement of the substances for both ground-based (including hand-held equipment) and aerial applications, predominantly for dicotyledonous plants, though under some scenarios monocotyledons are also at risk. With adherence to HSNO controls, including approved handler requirements, and adherence to the Code of Practice for the Management of Agrichemicals NZS8409:2004, the level of risk is assessed as medium to high. 4.21 GF-982, the export only substance, is classified as a 3.1D flammable liquid. Accordingly, effects on the environment could arise from an incident that results in the substance being released near an ignition source. Risks relating to fire have been discussed in paragraph 4.15 above, and are not considered to be different with regard to the environment. 4.22 Overall the level of risk to the biological and physical environment arising from the manufacture and normal use of aminopyralid compounds is considered by the Committee to be insignificant to low with the exception of spray drift onto terrestrial plants where the risks are medium to high. Compost Stream 4.23 Living Earth Limited submitted that aminopyralid contamination may have serious effects on commercial, home and vermi-composting. 4.24 Living Earth Limited based its claim on its experience with clopyralid-containing herbicides. Clopyralid is the active ingredient in a number of products used for the treatment of weeds in turf. It is a candidate for reassessment due to residues from use on turf not degrading during composting and potentially causing adverse effects on plants grown in that compost. In a decision dated 1 May 2002, the Authority found that there was sufficient new and significant information relating to the persistent effects of clopyralid in compost to provide grounds for its reassessment. 4.25 Given the structural similarity of aminopyralid to clopyralid, Living Earth Limited is concerned that similar problems with persistence in compost may occur. ERMA New Zealand Decision: Application HSR04025 Page 6 of 50 4.26 On behalf of Living Earth Limited, Perry Environmental Limited also discussed the potential effect the use of aminopyralid containing herbicides may have on the vermicomposting of paunch grass sourced from the freezing works industry. 4.27 Accordingly, Living Earth Limited requested the Authority to impose appropriate controls, including tracking and to raise the level of accountability by users to minimise any impact on the organic waste recovery industry. If the Authority is not able to achieve this outcome, Living Earth Limited requested that the Authority decline the application. 4.28 Living Earth Limited also asked that any approval should be subject to a review clause every three years to assess the effectiveness of controls and any impact aminopyralid may have on organic waste recovery. 4.29 The Committee notes that there is a structural similarity between aminopyralid and clopyralid and that the Authority has found that there are grounds for the reassessment of clopyralid. However, the significance of the effects of clopyralid on compost has yet to be assessed. This will occur when an application to reassess clopyralid-containing substances is received by ERMA New Zealand. 4.30 Given the structural similarity of aminopyralid to clopyralid, and the decreased degradation rate of aminopyralid at elevated temperatures (i.e., slower at 30ºC than at 20ºC) the Committee accepts that the release of aminopyralid-based herbicides poses potential risks to the composting industry. 4.31 In light of this, the Committee considers that the use of aminopyralid substances on turf should be prohibited. In addition to a prohibition appearing on the label, the Committee considers that it is important to highlight that the prohibition of using aminopyralid on turf is because of the potential impacts on compost. 4.32 Accordingly, the Committee requires that the following statements appear on the label: The product must not be used on turf. DO NOT use hay or other plant material harvested within 10 weeks of treatment with (tradename of substance) for making compost or mulching susceptible crops. DO NOT use plant material that has been treated with (tradename of substance) within the previous 10 weeks to make mushroom substrate. DO NOT use manure, paunch grass or dairy effluent from animals grazing areas treated with (tradename of substance) within the previous 10 weeks for making compost unless the clean feed withholding period has been observed. 4.33 The Committee also requires that information on the above restrictions should be provided in any material that accompanies the substances. 4.34 The Committee also considers that the substances should only be available in a minimum pack size of 1 L or 1 kg as a disincentive to purchase by domestic users and urban contractors. ERMA New Zealand Decision: Application HSR04025 Page 7 of 50 4.35 The Committee acknowledges the request from Living Earth for a three year review – but does not consider that setting a control for a review would be effective. The Committee is of the view that the option of a reassessment at any time if residues of aminopyralid are found will be more effective in addressing compost contamination issues. 4.36 The tracking control TR1 is triggered by the 9.2A classification of aminopyralid. The Committee considers that this requirement will not add to the management of risks associated with the substance during normal use. Risks to the environment which may arise other than during use are already addressed through packaging, identification, emergency management and other life-cycle related controls. 4.37 The Committee is also of the view that there is no benefit in adding a tracking control to assist enforcement of off-label use. It would be very unlikely that anyone who was using the substance illegally would note this in a spray diary or suchlike. It is the Committee’s view that it would be more effective to educate and have warnings on the labels of the potential impacts of off-label use. 4.38 However, the Committee considers that the 3 kg in 24 hours trigger level for the keeping of records of use should be reduced for GF-1397 to 1 L. The 3 L(kg) trigger level for the other formulations (GF-871, GF-839 and GF-1118) may be retained as the ultimate use of these has not been decided but it is expected that they will be used on woody weeds and the use volumes per day would be much higher than for GF-1397. The likely use volumes per day for GF-1397 would be in the order of 1 – 100 L per day and for the other formulations 3-50 L per day depending on whether applied by air or ground. Māori issues and concerns 4.39 The Committee has considered the potential Māori cultural effects in accordance with clauses 9(b)(i) and 9(c)(iv) of the Methodology and sections 6(d) and 8 of the HSNO Act. In addition, the Committee used the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the HSNO Act 1996” in assessing this application. 4.40 The Committee notes the lack of data specific to aminopyralid’s expected performance in New Zealand’s environment especially with regard to potential impact of adverse effects to non-target native flora and fauna both terrestrial and aquatic. 4.41 This lack of data and uncertainty makes it difficult to assess likelihood of potential adverse risk to Māori and their taonga. A high magnitude of impact upon kaitiakitanga through negative impacts upon the mauri of native terrestrial and aquatic flora and fauna species would be expected in the event of adverse effects developing from the use of aminopyralid based compounds. 4.42 From the information provided, the Committee considers that it is difficult to assess likelihood of impact on the relationship between Māori culture and their traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga. ERMA New Zealand Decision: Application HSR04025 Page 8 of 50 4.43 The Committee considers that culturally adverse risks will have parallel pathways of exposure to those posed by any potentially adverse physical environmental risks. Therefore strict adherence to controls and conditions for aminopyralid compound use will contribute to minimising the impact on Māori and their taonga 4.44 However, should inappropriate or accidental use, transport or disposal of the substance result in the contamination of waterways, it is suggested that the appropriate authorities, including the relevant iwi authorities, in the region are notified. This action should include advising them of the contamination and the measures taken in response. Benefits 4.45 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. 4.46 The applicant has asserted that the aminopyralid substances have the following benefits: The substances incorporate a new herbicidal active ingredient which is expected to have a lower potential for health and environmental impact than the substances they are intended to replace, or be an alternative to. Their manufacture in NZ will assist with the viability of the manufacturing plant that provides employment to approximately 50 people. These substances will assist in the control of economically troublesome pasture weeds. Beneficial effects – assessment 4.47 The Committee noted that the Agency has calculated risk quotients for comparative products. The outcome of the comparative assessment against ‘market standards’ indicates that substances containing aminopyralid present a potentially lower risk to the aquatic environment during use than those comparative products. 4.48 The applicant notes that the manufacture of these products at the plant in New Plymouth will assist in ensuring the viability of the plant. While this may be considered as primarily an impact on the market economy, there is a social component in that continued employment assists in maintaining the viability of the local community. The four products that are planned for the local market are expected to in part replace current products, and thus the effect may be neutral rather than positive. However, the intention to manufacture one product for the export market may have a positive social effect, in the circumstance that if the application were declined, the plant was downgraded and staff employment terminated. 4.49 As noted in the identification of beneficial social and community effects there are potentially beneficial effects to the market economy arising from the development of an export market for one of the products. ERMA New Zealand Decision: Application HSR04025 Page 9 of 50 4.50 The applicant has provided a significant amount of information about the economic cost of weeds to New Zealand, and notes that these products are intended to target the five weeds considered most troublesome by rural landowners. However, it is clear from the application that the products are not expected to target any different weeds to products already existing in the market. That is, these new products are expected to add to the tools available to farmers and other land managers. Establishment of the Approach to Risk in the Light of Risk Characteristics 4.51 In accordance with clause 33, the Committee has established a cautious position for these substances during its consideration since aminopyralid is a new active ingredient world-wide and there is a risk of contamination of compost should treated plant material enter the compost stream. Overall Evaluation of Risks, Costs and Benefits 4.52 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 proposed controls including default controls plus proposed variations to the controls. 4.53 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. 4.54 Overall the level of risk to the biological and physical environment arising from the manufacture and normal use of aminopyralid compounds is considered by the Committee to be insignificant to low with the exception of spray drift onto terrestrial plants where the risks are medium to high. 4.55 As discussed in paragraphs 4.29 and 4.30 above, the Committee accepts that the release of aminopyralid-based herbicides poses potential risks to the composting industry. 4.56 As discussed in paragraphs 4.39 to 4.43 above, the Committee considers that there are potential adverse effects to Māori and their taonga flora and fauna species, native ecosystems and natural resource practices. 4.57 As discussed in paragraphs 4.47 to 4.49 above, the Committee considers that there are potential benefits associated with the import and manufacture of the aminopyralid substances. 4.58 The applicant did not directly address the likely effects of aminopyralid being unavailable. However, the Committee considers the likely effects to be a reduction in user choice to use an alternative product in the control of weeds and loss of the potential benefits of using a lower risk substance. 4.59 While the substances pose a degree of risk to the environment and to human health and a potential risk to the organic waste recovery industry, the Committee is satisfied that, taking into account the imposition of additional controls, especially the restriction on use and the minimum pack size, the benefits of the introduction of novel substances with low ecotoxic properties outweigh the risks and their associated costs. ERMA New Zealand Decision: Application HSR04025 Page 10 of 50 Additional Controls under s77A 4.60 Under section 77A of the HSNO Act, 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 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. 4.61 The following additional controls are set by the Committee: 4.62 Aminopyralid shall be used for manufacturing purposes only. 4.63 The Committee considers that this additional control will be more effective in terms of its effect on the management, use, and risks of aminopyralid, (section 77A(4)(a)), as it considers that this restriction on the use will prevent additional risks that have not been assessed and therefore are not managed under the controls specified under section 77 of the Act. 4.64 GF-982 will be manufactured for export purposes only. 4.65 The Committee notes that GF-982 is being manufactured for export purposes only. The Committee considers that this additional control would be more effective in terms of its effect on the management, use, and risks of GF-982, as it considers that this restriction on the purposes will prevent additional risks that have not been assessed and therefore are not managed under the controls specified under section 77 of the Act. 4.66 GF-871, GF-389, GF-1118, GF-1397 shall only be used as herbicides for use in agriculture, forestry and non-crop situations and not for application to turf. 4.67 Given the risks to the composting industry, the Committee considers it appropriate to add an additional control to all substances containing aminopyralid, excluding turf management (s77A(4)), as it is considered that this restriction on the use will mitigate against these risks which are not managed under the controls specified under section 77 of the Act. 4.68 The Committee requires that the following statements appear on the label: The product must not be used on turf. DO NOT use hay or other plant material harvested within 10 weeks of treatment with (tradename of substance) for making compost or mulching susceptible crops. DO NOT use plant material that has been treated with (tradename of substance) within the previous 10 weeks to make mushroom substrate. DO NOT use manure, paunch grass or dairy effluent from animals grazing areas treated with (tradename of substance) within the previous 10 weeks for making compost unless the clean feed withholding period has been observed. ERMA New Zealand Decision: Application HSR04025 Page 11 of 50 4.69 The substances are to be available in a minimum pack size of 1 L or 1 kg. 4.70 The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, set out in Schedule 10 of the New Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35, as amended by the New Zealand Gazette Notice of Friday, 1 October 2004, Issue Number 128, shall apply to GF-982, as applicable, notwithstanding clause (1) of the schedule. 4.71 The Committee noted that, as a means of managing the risks from GF-982, the Act provides for regulations to be made, prescribing controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances (section 75(1)(b)). These provisions are currently in the form of controls on dangerous goods in Schedule 10 of the New Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35, as amended by the New Zealand Gazette Notice of Friday, 1 October 2004, Issue Number 128. 4.71.1 The Committee considers that controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, are necessary to manage GF-982, and noted that no other such controls have been specified under the Act. 4.71.2 In accordance with section 77A(4)(a) of the Act, 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 GF-982. 4.72 Control I19, alternative information. Regulation 30 allows for alternative labelling for substances in multiple packaging where some or all of the required information is obscured by outer packaging. The regulation does not allow for non-compliant labelling on inner packages of export-only products or for the minimal labelling of outer packaging or single containers of export-only products. Accordingly, the Committee considers that regulation 30 should be replaced by a control that is more cost effective in terms of its effect on the management, use, and risks of an export-only substance (section 77A(4)(b)). 4.73 The Committee considers the following control appropriate and notes that it is consistent with the controls set by the Authority in respect of export-only veterinary medicines. a) The outer packaging of a multiple package or the packaging of a single container, which is not contained within a multiple package, must bear: the priority identifier information required by regulations 8, 9, 11 and 14; or the labelling or marking required by i. Land Transport Rule 45001: Dangerous Goods 2005; or ii. Civil Aviation Rule 92: Carriage of Dangerous Goods); or iii. Maritime Rule 24A: Carriage of Cargoes - Dangerous Goods); or in the case of an ecotoxic substance, the pictogram for “Dangerous in the Environment” as described in directive 92/32/EEC; or the relevant class or subclass label assigned by the UN Model Regulations. b) GF-982 must be identified by enough information to enable its New Zealand supplier or manufacturer to be contacted, either in person or by telephone. ERMA New Zealand Decision: Application HSR04025 Page 12 of 50 c) GF-982 shall not have on it or its packaging, or with it, any information suggesting that it belongs to a class or subclass it does not in fact belong to. d) If the packaging of GF-982 complies with a) to c) above, it does not need to comply with the secondary identifier requirements of regulations 18, 19, 20, 22 and 25 of the Hazardous Substances (Identification) Regulations 2001. Variation of Controls under Section 77 4.74 Under section 77(3), (4) and (5), the default controls determined by the hazardous properties of the substance may be varied. 4.75 Following the identification and assessment of the effects of these substances, the Committee has reviewed the default controls and considers that it would be appropriate to make the following changes: Aminopyralid 4.76 The acceptable daily exposure (ADE) values and potential daily exposure (PDE) values determined by the Agency were inadvertently omitted from the E&R Report. These values are required by the New Zealand Food Safety Authority for the setting of a maximum residue level (MRL). Accordingly, the Committee has set the following exposure values for aminopyralid: ADE = 0.5 mg/kg bw/day PDEFOOD = 0.4 mg/kg bw/day PDEDRINKING WATER = 0.1 mg/kg bw/day. 4.77 Controls T4 and E6 are combined (section 77(5)) as they both relate to the same regulation pertaining to requirements for equipment used to handle hazardous substances. 4.78 Control E1 requires that Environmental Exposure Limits (EELs) be established. The Committee considers that, given the proposed use pattern of the substance, any environmental exposure is highly unlikely. The Committee therefore considers no EELs need to be set for Aminopyralid and the default EEL values can be deleted under section 77(4)(a). 4.79 Controls P3 and P14 are combined (section 77(5)) as appropriate as they both relate to packaging requirements for the substance. 4.80 Controls D4 and D5 are combined (section 77(5)) as they both relate to disposal requirements for the substance. 4.81 Control TR1 is triggered by the 9.2A classification of aminopyralid. This control will not add to the management or risks associated with the substance during the lifecycle, accordingly this control is deleted under section 77(4)(b). Any risks that may arise are already sufficiently addressed though packaging, identification, emergency management and other lifecycle related controls. ERMA New Zealand Decision: Application HSR04025 Page 13 of 50 4.82 Controls AH1 and E7 are triggered by the 9.2A classification of aminopyralid. Given the substance is solely intended for use in manufacturing pesticides, and the environmental risks are insignificant, the Committee considers that it is appropriate that the approved handler controls (AH1 and E7) be deleted under section 77(4)(a). GF-871, GF-389, GF-1118, GF-1397 4.83 Control E1 requires that Environmental Exposure Limits (EELs) be established. The Committee considers that the following EELs, should apply to GF-871, GF-389, GF1118, GF-1397: Aminopyralid, EEL water = 0.06 mg/L water Aminopyralid, EEL soil = 0.00002 mg/kg Aminopyralid, EEL surface deposition = 0.005 g/ha. 4.84 Control E2 requires that a maximum application rate be established if an EEL is established for a substance used on an area of land. The Committee has adopted the following application rates and frequencies as proposed by the applicant: – broadleaf weeds 60 g a.e/ha; one application per year – brushweeds 260 g a.e./ha; one application per year. 4.85 Control E3 requires that a person using GF-871; GF-1397; GF-389; GF-1118 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 Committee considers that trigger quantities should be reduced to 1 L for GF-1397 (section 77(3)(a). 4.86 Control TR1 is triggered by the 9.2A classification of aminopyralid. The Committee considers that this requirement will not add to the management of risks associated with the substance during use. The Committee also considers that there is no benefit in imposing a tracking control with the intention of managing off-label use. Accordingly, the Committee has deleted this control under section 77(4)(b) of the Act. 4.87 Controls AH1 and E7 are triggered by the 9.2A classification of substances containing aminopyralid. Given the risks to non-target plants as identified in the risk assessment, the Committee considers that it is appropriate that the approved handler control remain for all end-use products containing aminopyralid, for the use-phase of the lifecycle by all users of the substances. GF-982 (Export only) 4.88 Control T1 relates to limiting exposure to toxic substances. The Committee does not consider that a TEL needs to be set as GF-982 is not intended for use in New Zealand. 4.89 Control T2 relates to the requirement to set Workplace Exposure Standards (WES). The Committee notes that no WES value has been set for aminopyralid or for any other component in the substances by the Occupational Safety and Health Service, Department of Labour. In the absence of relevant industrial hygiene data with respect to the use of this substance in New Zealand, the Committee considers that no WES value should be set for aminopyralid at this time. ERMA New Zealand Decision: Application HSR04025 Page 14 of 50 4.90 Controls T4 and E6, relating to equipment used to handle substances are combined (section 77(5)) and limited to the manufacturing phase of the lifecycle under section 77(4)(a). 4.91 Controls F2 and T7, relating to carriage on passenger service vehicles, are not applicable to the intended use of GF-982 and are deleted under section 77(4)(a). 4.92 Control T8, specifying requirements for class 6.1 substances that are (lawfully) laid or applied outdoors for terrestrial vertebrate pest control, is not applicable to the intended use of GF-982. 4.93 Control E1 requires that Environmental Exposure Limits (EELs) be established. The Committee considers that, given the proposed use pattern of the substance, any environmental exposure is highly unlikely. The Committee therefore considers no EELs need to be set for GF-982 and the default EEL values are deleted under section 77(4)(a). 4.94 Control E2, specifying requirements relating to application areas, is not applicable as this control only applies to substances intended to be applied to an area of land, air or water. 4.95 Control E5 relates to requirements for keeping records of use when a substance is applied into the environment for the purposes of causing biocidal action. Given GF-982 is solely intended for use in the manufacture of herbicides, this control is not applicable. 4.96 Identification information on a label of an export-only product is relevant and should be required for single containers and for outer packaging on multiple packages. However, it is not considered relevant and should not be required for inner packages of a multiple package. Accordingly, the Committee proposes the following variations to the identification controls: 4.97 Control I1, general identification requirements. Controls I2, I3, I5, I9, I10, I11, I13, I16, priority and secondary identifiers, Regulations 6, 7, 8, 9, 11, 14, 18, 19, 20, 22, 25 32, 33, 34, 35, 36(1)-(7) of the Hazardous Substances (Identification) Regulations 2001. The Committee considers that the priority and secondary identifier information requirements should not apply to GF-982 contained within the inner packaging of multiple packaging (section 77(4)(a)). 4.98 In addition, the Committee considers that Regulation 19(f), the identification of ingredients, should not apply to single containers of GF-982 and this control is deleted under section 77(4)(a). 4.99 Control D7, disposal information requirements. This control is not applicable to an export-only product and is deleted under section 77(4)(a). 4.100 Controls EM1, EM2, EM6 and EM7, level 1 information requirements. Emergency Management Regulations 6 to 11. The Committee considers level 1 information on a label is not relevant to an export-only product and these controls are deleted under section 77(4)(a). ERMA New Zealand Decision: Application HSR04025 Page 15 of 50 4.101 Control TR1 is triggered by the 9.2A classification of aminopyralid. The Committee considers that this requirement will not add to the management of risks associated with the export of this substance. Risks which may arise are already addressed through packaging, identification, emergency management and other life-cycle related controls. Accordingly, the Committee has deleted this control under section 77(4)(b). 4.102 Controls AH1 and E7 are triggered by the 9.2A classification of substances containing aminopyralid. Given the substance is solely intended for export, and the environmental risks are insignificant, the Committee considers that it is appropriate that the approved handler controls (AH1 and E7) are deleted under section 77(4)(a). Recommendations 4.103 The Committee recommends that the applicant should provide information to the turf industry and distributors explaining there are potential risks to compost. 4.104 The Committee recommends that, should inappropriate or accidental use, transport or disposal of aminopyralid or aminopyralid containing substances 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 4.105 The Committee considers that use of controls on aminopyralid or aminopyralid containing substances is an effective means of managing risks associated with these substances. At this time no consideration has been given to whether or not environmental charges should be applied to these substances as an alternative or additional means of achieving effective risk management. 5 Decision 5.1 Pursuant to section 29 of the HSNO Act, the Committee has considered this application to import and manufacture hazardous substances made under section 28 of the HSNO Act. 5.2 The Committee is satisfied that the default controls, as varied in paragraphs 4.61 to 4.102 above, will be adequate to manage the adverse effects of the substances. 5.3 Having considered all the possible effects of the hazardous substances in accordance with section 29 of the HSNO Act, pursuant to clause 27 of the Methodology, based on consideration and analysis of the information provided, and taking into account the application of controls, the view of the Committee is, while the substances pose risks to the environment, to human health and safety, to the composting industry and to Maori, that the benefits associated with the substances outweigh the risks and costs. 5.4 In accordance with clause 36(2)(b) of the Methodology the Committee records that, in reaching this conclusion, it has applied the balancing tests in section 29 of the HSNO Act and clause 27 of the Methodology. ERMA New Zealand Decision: Application HSR04025 Page 16 of 50 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; clause 14 – costs and benefits accruing to New Zealand clause 21 – the decision accords with the requirements of the HSNO Act 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. 5.6 The application for importation and manufacture of the hazardous substances Aminopyralid, GF-389, GF-871, GF-982, GF-1118 and GF-1397 is thus approved, with controls as detailed in Appendix 1. Tony Haggerty Date 30 August 2005 Chair Hazardous Substances Committee ERMA New Zealand Approval Code: Aminopyralid GF-389 GF-871 GF-982 GF-1118 GF-1397 HSR001684 HSR001687 HSR001688 HSR001689 HSR001685 HSR001686 ERMA New Zealand Decision: Application HSR04025 Page 17 of 50 Appendix 1: List of Controls for Aminopyralid substances Control Codes and Explanations – Aminopyralid Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T4, E6 7 Requirements for equipment used to handle hazardous substances Any equipment used to handle aminopyralid 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. T5 8 Requirements for protective clothing and equipment Protective clothing/equipment must be employed when aminopyralid 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. T7 10 Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for public exposure to hazardous substances, the following requirements are prescribed for the carriage of aminopyralid on passenger service vehicles: the maximum quantity per package of aminopyralid permitted to be carried on passenger service vehicles is 2 kg Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls 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 MSDS 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)) 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 HSR04025 Page 18 of 50 Control Code1 Regulation2 Explanation3 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 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 2 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. I2 8 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 and 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 corrosive substances This requirement specifies that aminopyralid 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. ERMA New Zealand Decision: Application HSR04025 Page 19 of 50 Control Code1 Regulation2 I3 9 I9 18 I10 19 I11 20 Explanation3 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 aminopyralid 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. Secondary identifiers for all hazardous substances This control relates to detail required for hazardous substances 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 (eg. 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 aminopyralid Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for aminopyralid. 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 (eg. harmful to aquatic life) an indication of its general type of hazard (eg. very ecotoxic in the soil environment) ERMA New Zealand Decision: Application HSR04025 Page 20 of 50 Control Code1 I17 Regulation2 26 I18 27 I19 29-31 Explanation3 Use of Generic Names This control provides the option of using a generic name to identify specific ingredients (or groups of ingredients) where such ingredients are required to be listed on the product label as specified by Regulation 19(f). 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 Regulation 19(f). 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 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. Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for hazardous substances that are imported into New Zealand in a closed package or in a freight container and will be transported to their 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. ERMA New Zealand Decision: Application HSR04025 Page 21 of 50 Control Code1 I21 Regulation2 37-39, 47-50 Explanation3 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 aminopyralid is held in the workplace in quantities equal to or greater than 2 kg. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity of aminopyralid equal to or greater than 2 kg, 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 aminopyralid 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 aminopyralid must include the 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 Aminopyralid. 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 ERMA New Zealand Decision: Application HSR04025 Page 22 of 50 Control Code1 Regulation2 Explanation3 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 0.3m. 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. I22 40 I23 41 I29 51-52 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 aminopyralid must include the following information: its general degree and type of corrosive hazard (eg. corrosive to eyes) 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 its pH or pH range. Specific documentation requirements for ecotoxic substances The documentation provided with aminopyralid must include the following information: its general degree and type of ecotoxic hazard (eg. highly ecotoxic to the soil environment; toxic to the aquatic environment) 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. 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 aminopyralid is held in quantities exceeding 100 kg. ERMA New Zealand Decision: Application HSR04025 Page 23 of 50 Control Code1 Regulation2 Explanation3 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 (e.g. flammable) 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 corrosive and toxic substances Any advertisement for aminopyralid substance 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. 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. ERMA New Zealand Decision: Application HSR04025 Page 24 of 50 Control Code1 Regulation2 Explanation3 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 9.B – Large Packaging Large packaging may be used to contain hazardous substances in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. P3, P14 9, 20 PG3 Schedule 3 PS4 Schedule 4 “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004, or a stationary container system, a stationary tank or a tank (as defined in the Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for corrosive substances (class 8) Aminopyralid in quantities of more than 2 kg must be packaged according to Schedule 3 (UN PGIII), but may be packaged according to either Schedule 3 or Schedule 4 when in quantities equal to or less than 2kg. Aminopyralid that is offered for sale in a package of less than 2.5kg must be in child resistant packaging. However, if the substance is for use in a place of work to which children to 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 2 kg. 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 2 kg. Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for toxic and corrosive substances Aminopyralid must be disposed of by: treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to discharge to the environment; or discharging 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 TEL (tolerable exposure limit) or EEL (environmental exposure limit) 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 aminopyralid 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 ERMA New Zealand Decision: Application HSR04025 Page 25 of 50 Control Code1 Regulation2 D7 11, 12 D8 13, 14 Explanation3 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 a quantity of aminopyralid that exceeds 0.1 kg. 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 a SDS) that must be provided when selling or supplying a quantity of aminopyralid that exceeds 2 kg. 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 aminopyralid when present in quantities equal to or greater than 0.1 kg. 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) EM7 8(f) 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 aminopyralid when present in quantities equal to or greater than 0.1 kg. 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 ecotoxic substances The following information must be provided with aminopyralid when present in quantities equal to or greater than 0.1 kg. a description of the parts of the environment likely to be immediately affected by it: ERMA New Zealand Decision: Application HSR04025 Page 26 of 50 Control Code1 Regulation2 EM8 12-16, 18-20 Explanation3 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 information 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 aminopyralid is sold or supplied, or held in a workplace, in quantities equal to or greater than 2 kg. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM11 EM13 25-34 42 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where aminopyralid is held (or reasonably likely to be held on occasion) in quantities greater than 1000 kg. 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 – signage This control relates to the provision of emergency management information on signage at places where aminopyralid is held at quantities equal to or greater than 100 kg. 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. Additional control under section 77A Aminopyralid shall be used for manufacturing purposes only ERMA New Zealand Decision: Application HSR04025 Page 27 of 50 Control Codes and Explanations – GF-871; GF-1397; GF-389; GF-1118. Control Code4 Regulation5 Explanation6 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 E2 46-48 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 (eg. soil or sediment or water), including deposition of a substance onto surfaces (eg. 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. The following EELs are set: Aminopyralid, EEL water = 0.06 mg/L water Aminopyralid, EEL soil = 0.00002 mg/kg Aminopyralid, EEL surface deposition = 0.005 g/ha 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 (eg. 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. In recognition of the need to limit adverse effects within the target area, Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. The application rate must not be greater than the application rate specified in the application for approval, or not greater than a rate calculated in a similar manner to that used to calculate EELs (with the proviso that the product of the uncertainty factors must not exceed 100). E5 5(2), 6 The following application rates are set: broadleaf weeds 60 g a.e/ha; one application per year brushweeds 260 g a.e./ha; one application per year. Requirements for keeping records of use A person using GF-1397 for the purposes of causing biocidal action must keep written records of that use if 1 L 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. 4 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. 5 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. 6 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 HSR04025 Page 28 of 50 Control Code4 Regulation5 E6 7 E7 9 Explanation6 A person using GF-871; GF-389; GF-1118 for the purposes of causing biocidal action must keep written records of that use if 3 kg or 3 L 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 Any equipment used to handle ecotoxic substances (eg. 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. Approved handler requirements GF-871; GF-1397; GF-389; and GF-1118 must be under the personal control of an approved handler when used by any user. However, the 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. 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 MSDS 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. ERMA New Zealand Decision: Application HSR04025 Page 29 of 50 Control Code4 Regulation5 Explanation6 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 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 2 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 I9 18 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 and 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 GF-871; GF-1397; GF-389; GF-1118 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. Secondary identifiers for all hazardous substances This control relates to detail required for GF-871; GF-1397; GF-389; GF1118 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. ERMA New Zealand Decision: Application HSR04025 Page 30 of 50 Control Code4 I11 Regulation5 20 I19 29-31 Explanation6 Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for GF-871; GF1397; GF-389; GF-1118. 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 GF-871; GF-389; GF-1118 (9.1C), an indication of its general type and degree of hazard (eg. very toxic to aquatic life) in the case of GF-871; GF-1397; GF-389; GF-1118, (9.2A) an indication of its general type of hazard (eg. ecotoxic to terrestrial invertebrates) 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 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. Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for hazardous substances that are imported into New Zealand in a closed package or in a freight container and will be transported to their destination without being ERMA New Zealand Decision: Application HSR04025 Page 31 of 50 Control Code4 Regulation5 I21 37-39, 47-50 Explanation6 removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is labelled or marked in compliance with the requirements of the Land Transport Rule 45001. Documentation required in places of work These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets) (Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when GF-871; GF-1397; GF-389; or GF-1118 are held in the workplace in quantities equal to or greater than the 5 L or 5 kg. 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 GF-871; GF-1397; GF-389; or GF-1118 equal to or greater than equal to or greater than the 5 L or 5 kg, 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 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 (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 ERMA New Zealand Decision: Application HSR04025 Page 32 of 50 Control Code4 Regulation5 Explanation6 Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (eg. as provided on a 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 0.3m. 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 GF-871; GF-1397; GF-389; or GF-1118 must include the following information: I29 51-52 its general degree and type of ecotoxic hazard (eg. 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. 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 GF-871; GF-1397; GF-389; or GF-1118 is held in quantities exceeding 100 L or 100 kg. 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. ERMA New Zealand Decision: Application HSR04025 Page 33 of 50 Control Code4 Regulation5 Explanation6 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 (eg. a 'No Smoking' warning near flammable substances). 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 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 9.B – 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: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004, or ERMA New Zealand Decision: Application HSR04025 Page 34 of 50 Control Code4 Regulation5 Explanation6 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. P3 9 Packaging requirements for substances packed in limited quantities When GF-871; GF-1397; GF-389; or GF-1118 is packaged in a maximum quantity of 450 L or 400kg, it may be packaged to a lesser performance standard than normally required (as specified in Schedule 4 of the Packaging Regulations). PS4 Schedule 4 This schedule describes the (minimum) packaging requirements that must be complied with for this substance. Hazardous Substances (Disposal) Regulations 2001 D5 9 Disposal requirements for ecotoxic substances GF-871; GF-1397; GF-389; or GF-1118 must be disposed of by: treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to discharge to the environment; or discharging 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) 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 GF871; GF-1397; GF-389; or GF-1118 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 0.1 kg or 0.1 L of GF-871; GF-1397; GF-389; or GF-1118 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 a SDS) that must be provided when selling or supplying a quantity of a GF-871; GF-1397; GF-389; or GF-1118 that exceeds 5kg or 5 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 ERMA New Zealand Decision: Application HSR04025 Page 35 of 50 Control Code4 Regulation5 Explanation6 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 GF-871; GF-1397; GF389; or GF-1118 when present in quantities equal to or greater than 0.1 L or 0.1 kg. 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)). 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 ecotoxic substances The following information must be provided with GF-871; GF-1397; GF389; or GF-1118 when present in quantities equal to or greater 0.1 L or 0.1 kg. 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 information 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 GF-871; GF-1397; GF-389; or GF-1118 is sold or supplied, or held in a workplace, in quantities equal to or greater than 5 L or 5 kg. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM11 25-34 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where GF-871; GF389; or GF-1118 is held (or reasonably likely to be held on occasion) in quantities greater than 1000 L or 1000 kg. ERMA New Zealand Decision: Application HSR04025 Page 36 of 50 Control Code4 EM12 EM13 Regulation5 35-41 42 Explanation6 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 liquid (or liquefiable) hazardous substances are held in quantities equal to or greater than 1000 L. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60L and 450L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450L. 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 exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained). Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where GF-871; GF-1397; GF-389; or GF-1118 is held at quantities equal to or greater than 100 L or 100 kg. 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 GF-871; GF-1397; GF-389; and GF-1118 are required to be under the control of an approved handler during when used (see Control E7). 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. ERMA New Zealand Decision: Application HSR04025 Page 37 of 50 Control Code4 Regulation5 Explanation6 Additional controls under section 77A GF-871, GF-389, GF-1118, GF-1397 shall only be used as herbicides for use in agriculture, forestry and non-crop situations and not for application to turf. The following statements must appear on the substance label: THE PRODUCT MUST NOT BE USED ON TURF. DO NOT use hay or other plant material harvested within 10 weeks of treatment with (name of substance) for making compost or mulching susceptible crops. DO NOT use plant material that has been treated with (name of substance) within the previous 10 weeks to make mushroom substrate. DO NOT use manure, paunch grass or dairy effluent from animals grazing areas treated with (name of substance) within the previous 10 weeks for making compost unless the clean feed withholding period has been observed. Information on the above restrictions should be provided in any material that accompanies the substances. The substances are to be available in a minimum pack size of 1 L or 1 kg ERMA New Zealand Decision: Application HSR04025 Page 38 of 50 Control Codes and Explanations GF-982 (Export-only) Control Code7 Regulation8 Explanation9 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property Controls F6 60-70 Requirements to reduce the likelihood of unintended ignition of class 3.1 substances. These regulations prescribe controls to reduce the likelihood of unintended ignition of GF-982. 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 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 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, 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. F11 76 It should be noted that any person handling any quantity of a class 2.1.1, 2.1.2 or 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 GF-982, there is a requirement to ensure that the substance 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. 7 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. 8 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. 9 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 HSR04025 Page 39 of 50 Control Code7 Regulation8 Explanation9 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T4, E6 7 Requirements for equipment used to handle hazardous substances Any equipment used to handle GF-982 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. T5 8 Requirements for protective clothing and equipment Protective clothing/equipment must be employed when GF-982 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. Hazardous Substances (Identification) Regulations 2001 As GF-982 is an export only product: I1 6, 7, 32-35, 36 (1)-(7) The standard labelling requirements should not apply to substances contained within the inner packaging of multiple packaging. Regulation 30 is replaced under section 77A with a control specifically drafted to address identification of export-only substances in multiple packaging and single containers. General identification requirements 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 ERMA New Zealand Decision: Application HSR04025 Page 40 of 50 Control Code7 Regulation8 Explanation9 information 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 2 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. 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 and 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. I2 8 These regulations do not apply to GF-982 contained within the inner packaging of multiple packaging. Priority identifiers for corrosive substances This requirement specifies that GF-982 must be prominently identified as being corrosive. 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. I3 9 This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging. Priority identifiers for ecotoxic substances This requirement specifies that GF-982 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. I5 11 This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging. Priority identifiers for flammable substances This requirement specifies that GF-982 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 ERMA New Zealand Decision: Application HSR04025 Page 41 of 50 Control Code7 Regulation8 Explanation9 if a flammable liquid, information must be provided on its general degree of hazard (eg. 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. I9 I10 I11 18 19 20 This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging Secondary identifiers for all hazardous substances This control relates to detail required for GF-982 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. This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging Secondary identifiers for corrosive substances This control relates to the additional label detail required for GF-982. 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 (eg. highly corrosive to the eyes) an indication of the circumstances in which it may harm 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 This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging. Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for GF-982. 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 9.1B, an indication of its general type and degree of hazard (eg. toxic to aquatic life) in the case of an ecotoxic substance of classification 9.2A, an indication ERMA New Zealand Decision: Application HSR04025 Page 42 of 50 Control Code7 I13 I16 I19 Regulation8 22 25 29 Explanation9 of its general type of hazard (eg. very ecotoxic to the soil environment) This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging. Secondary identifiers for flammable substances This control relates to the additional label detail required for GF-982. 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 (eg. low hazard flammable liquid) an indication of the circumstances in which it may be ignited unintentionally an indication of the likely effect of an unintentional ignition an indication of the steps to be taken to prevent an unintentional ignition. This regulation does not apply to GF-982 contained within the inner packaging of multiple packaging. Secondary identifiers for toxic substances This control relates to the additional label detail required for GF-982. 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. This regulation should not apply to GF-982 contained within the inner packaging of multiple packaging. 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 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. ERMA New Zealand Decision: Application HSR04025 Page 43 of 50 Control Code7 Regulation8 Explanation9 Export-only substances The outer packaging of a multiple package or the packaging of a single container which is not contained within a multiple package must bear: the priority identifier information required by regulations 8, 9, 11 and 14 of the Hazardous Substances (Identification) Regulations 2001; or the labelling or marking required by o Land Transport Rule 45001: Dangerous Goods 2005; or o Civil Aviation Rule 92: Carriage of Dangerous Goods); or o Maritime Rule 24A: Carriage of Cargoes - Dangerous Goods); or The pictogram for “Dangerous in the Environment” as described in directive 92/32/EEC; or The relevant class or subclass label assigned by the UN model Regulations. GF-982 must be identified by enough information to enable its New Zealand supplier or manufacturer to be contacted, either in person or by telephone GF-982 shall not have on its packaging, or with it, any information suggesting that it belongs to a class or subclass it does not in fact belong to. I21 37-39, 47-50 If the packaging of GF-982 complies with these requirements, it does not need to comply with the secondary identifier requirements of regulations 18, 19, 20, 22 and 25 of the Hazardous Substances (Identification) Regulations 2001. 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 Material 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 GF-982 is held in the workplace in quantities equal to or greater than the 1 L. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity GF-982 equal to or greater 1L, 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 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 ERMA New Zealand Decision: Application HSR04025 Page 44 of 50 Control Code7 Regulation8 Explanation9 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 (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 Aminopyralid (tech) Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (eg. as provided on a 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 0.3m. 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. 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. ERMA New Zealand Decision: Application HSR04025 Page 45 of 50 Control Code7 I22 Regulation8 40 I23 41 I25 43 I28 46 Explanation9 Specific documentation requirements for corrosive substances The documentation provided with GF-982 must include the following information: its general degree and type of corrosive hazard (eg. corrosive to the eyes) 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 GF-982 must include the following information: its general degree and type of ecotoxic hazard (eg. toxic to the aquatic environment; highly toxic to the soil environment) 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 GF-982 must include the following information: its general degree and type of flammable 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 GF-982 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 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 (toxic) 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 ERMA New Zealand Decision: Application HSR04025 Page 46 of 50 Control Code7 Regulation8 I29 51-52 Explanation9 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 GF-982 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 (e.g. flammable) 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). 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 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 ERMA New Zealand Decision: Application HSR04025 Page 47 of 50 Control Code7 Regulation8 Explanation9 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 9.B – Large Packaging Large packaging may be used to contain hazardous substances in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. P3, P13, P14, P15 9, 19, 20, 21 PG3 Schedule 3 PS4 Schedule 4 “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004, or a stationary container system, a stationary tank or a tank (as defined in the Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for corrosive substances (class 8) GF-982 in quantities of more than 1L must be packaged according to Schedule 3 (UN PGIII), but may be packaged according to either Schedule 3 or Schedule 4 when in quantities equal to or less than 1L. This schedule describes the (minimum) packaging requirements that must be complied with for this substance when packaged in quantities of more than 1 L. 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, 6, 8, 9 Disposal requirements for flammable substances D5 GF-982 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 exporting the substance from New Zealand as a hazardous waste. However, there is provision for GF-982 to be discharged into the environment as waste or deposited 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. ERMA New Zealand Decision: Application HSR04025 Page 48 of 50 Control Code7 D6 Regulation8 10 D8 13, 14 Explanation9 Disposal requirements for packages This control gives the disposal requirements for packages that contained GF982 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 documentation requirements These controls relate to the provision of documentation concerning disposal (essentially in a SDS) that must be provided when selling or supplying a quantity of GF-982 that exceeds 1 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 EM8 12-16, 18-20 Level 2 emergency management information 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 GF-982 is sold or supplied, or held in a workplace, in quantities equal to or greater than the 1 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 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 and oxidising substances and organic peroxides There is an additional requirement for GF-982 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 GF-982 is held in a place of work in quantities exceeding 500 L must have 2 fire extinguishers. 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 ERMA New Zealand Decision: Application HSR04025 Page 49 of 50 Control Code7 Regulation8 EM11 25-34 EM12 EM13 35-41 42 Explanation9 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 GF-982 is held (or reasonably likely to be held on occasion) in quantities greater than 1000 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 GF-982 is held in quantities equal to or greater than 1000 L. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60L and 450L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450L. 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 exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained). Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where GF-982 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. Additional controls under section 77A GF-982 will be manufactured for export purposes only. The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, set out in Schedule 10 of the New Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35, as amended by the New Zealand Gazette Notice of Friday, 1 October 2004, Issue Number 128, shall apply, as applicable, notwithstanding clause (1) of the schedule ERMA New Zealand Decision: Application HSR04025 Page 50 of 50