ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 21 June 2002 Application code HSR02001 Application type To import or manufacture any hazardous substance under section 28 of the Hazardous Substances and New Organisms (HSNO) Act 1996 Applicant Osmose New Zealand Purpose To manufacture a combination fungicide/insecticide treatment for timber and wood products Date received 18 January 2002 Consideration date 17 May 2002 Considered by The Hazardous Substances Committee of the Authority 1 Summary of Decision 1.1 The application to manufacture Protim Optimum is approved with controls in accordance with section 29 and other relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998. The approval is for import or manufacture. 1.2 The hazardous substances have been given the unique identifier "Protim Optimum" for the ERMA New Zealand Hazardous Substances Register. 1.3 ERMA New Zealand has adopted the use classification system as the basis for recording the nature and uses of substances approved. The following use categories are recorded for the two variants of this substance: Main category Industry category Function/use category 3 0 39 Non-dispersive use Other Pesticides, non-agricultural Environmental Risk Management Authority Decision: Application (HSR02001) Page 1 of 38 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 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 Hazardous Substances and New Organisms (Methodology) Order 1998 (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 18 January 2002. On 24 January, further information was requested from the applicant, under section 52 of the HSNO Act, and the application was stalled until 4 February when this information was received. The application was verified on 5 February. 3.2 The application was publicly notified on 13 February in The Dominion, The New Zealand Herald, The Christchurch Press, and The Otago Daily Times (clauses 2(b) & 7, section 53(1) and 53A). Government Departments, Crown Entities, and interested parties, which in the opinion of the Authority would be likely to have an interest in the application, were also notified (clause 2(2)(e), section 53(4)). Submissions were received from: The Occupational Safety and Health Service of the Department of Labour, Environment Canterbury, Tasman District Council, Taranaki Regional Council, The Ministry of Agriculture and Forestry, The Ministry for the Environment, The Ministry of Health, and Te Runanga o Ngati Whatua. 3.3 One request for a hearing was received but this was withdrawn after a meeting between the applicant and the requester was held. 3.4 No external experts were used in the considering of this application (clause 17). 3.5 The information available to the Committee comprised: The application, including as attachments: Confidential information on manufacturing details, formulation, and data on the components. References Further information requested (section 52(1)) on: What would be used to clean up spillages?, and Environmental Risk Management Authority Decision: Application (HSR02001) Page 2 of 38 How bound is the substance in wood, e.g under what circumstances would it leach out? The ERMA New Zealand Evaluation and Review (E&R) Report including comments from government departments and the submissions. 3.6 Members of the Hazardous Substances Standing Committee of the Authority: Jill White (Chairperson), Prof. George Clark, and Prof. Colin Mantell, considered the application (section 19(2)(b)). 3.7 The statutory time frame for the consideration of the application was formally extended under section 59 of the HSNO Act, to 14 June 2002, with the agreement of the applicant. 3.8 The completion of the consideration still exceeded the extended timeline. No formal waiver was sought for this because the delays were largely unavoidable. They arose from “first of a kind” status of the application and the need to resolve a number of policy issues as the consideration proceeded. 4 Consideration Purpose of the Application 4.1 PROTIM OPTIMUM is the trade name of a substance which contains a mixture of azoles (0.7% tebuconazole and 0.7% propiconazole) as the active ingredient fungicides and permethrin as the insecticide. The active ingredients are dissolved in the white spirits and the proprietary water repellent system. The confidential specification gives the identity of the active ingredient and outlines CAS numbers, proportions and functions of the components of the substance. 4.2 The intended use of the product is as a light organic solvent (LOSP) type timber preservative for use in purpose built industrial treatment plants. Initially the treated wood will be exported to the US, but as the market develops, the treated wood may also be used locally. 4.3 PROTIM OPTIMUM triggers thresholds for flammability (3.1C), toxicity (6.1E, 6.3B, 6.9B), and ecotoxicity (9.1A, 9.4B). Sequence of the Consideration and the Approach Adopted 4.4 In accordance with clause 24 of the Methodology, the approach adopted by the Committee was to: Establish the hazard classifications for the substance and derive the default controls. Identify potentially non-negligible risks, costs, and benefits. Environmental Risk Management Authority Decision: Application (HSR02001) Page 3 of 38 4.5 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 of the Methodology. Consider and determine variations to the default controls arising from the circumstances provided for in sections 77 (3), (4) and (5) of the Act and then consolidate controls. Evaluate overall risks, costs, and benefits to reach a decision. The combined impact of risks, costs and benefits was evaluated in accordance with clause 34, and the cost-effectiveness of the application of controls was considered in accordance with clause 35. The approach used and set out above meets the requirements of clause 24 of the methodology ie the need to use recognised risk identification, assessment, evaluation, and management techniques. Hazard Classification of Substance 4.6 In determining the appropriate hazard classifications for the substance, the Committee considered both the classifications proposed by the applicant, and variations to those classifications proposed in the E&R Report. The Committee agreed with the alternative analyses in the E&R Report, and the reasons for this are briefly summarised in the table below, Protim Optimum is therefore classified as follows: Hazardous Property Threshold Explosiveness Flammability Liquid Not triggered Oxidising Capacity Not triggered Corrosiveness Metal Skin Eye Triggered Classification Reasons for classification where the E&R Report differs from applicant 3.1C (closed-cup flashpoint 38°C) Not triggered Not triggered Not triggered Environmental Risk Management Authority Decision: Application (HSR02001) Page 4 of 38 Toxicity Acute toxicity Triggered 6.1E 6.3B Skin irritation Eye irritation Triggered Not triggered Sensitisation Not triggered Mutagenicity Carcinogenicity Reproductive/dev elopmental Target organ/systemic Not triggered Not triggered Not triggered Triggered Applicant used components in applying the mixture rules that did not need to be included. ERMA NZ also found additional data supporting a higher LD50 value for white spirits. ERMA NZ found additional data to indicate that the substance does not trigger the eye irritancy threshold. Although data supplied by the applicant indicates that two components are sensitisers, their concentrations in the substance are below the GHS cutoff levels and ERMA NZ is not aware of any research investigating sensitisation effects at concentrations below this level. 6.9B Ecotoxicity Aquatic Soil Triggered Not triggered Terrestrial vertebrate Not triggered 9.1A Although the applicant has supplied data to suggest that tebuconazole is soil ecotoxic, the concentration of tebuconazole in the substance is not high enough for the substance to trigger the threshold. The avian data supplied by the applicant indicates that the substance would not trigger the threshold. Environmental Risk Management Authority Decision: Application (HSR02001) Page 5 of 38 Terrestrial invertebrate Triggered 9.4B Although the applicant has supplied data to indicate that permethrin triggers a 9.4A classification, when mixture rules are applied, the substance only triggers a 9.4B classification. Default Controls 4.7 The default controls associated with above classifications are identified in the E&R Report (at section 6.3), and are not reproduced here. The Committee's view was that the E&R Report correctly assigned default controls as set out in the HSNO Regulations. They were used as the reference for subsequent consideration of the application. Identification of the Potentially Non-negligible Risks, Costs, and Benefits of the Substance 4.8 The Committee identified potentially non-negligible risks, costs and benefits with reference to clauses 9 and 11 of the Methodology, which incorporate relevant material from sections 2, 5, 6, and 8 of the Act. Risks 4.9 The Committee reviewed the identification of risks made by the applicant and additional risks identified in the E & R Report. The Committee did not identify any further additional risks. From all of those risks, the Committee identified those summarised in the table below as those which were potentially non-negligible and thus warranted more detailed assessment. Area of impact Stage in life cycle Transport of substance Use of substance in timber treatment including storage Biological and physical environment Exposure of the aquatic environment or of valued terrestrial invertebrates due to accident and spillage during road transport. Exposure of valued terrestial invertebrates and exposure of the aquatic environment due to spillage in use. Human health and safety - Exposure of workers in the treatment plant due to spillage of the substance in use or during transfer from storage. Environmental Risk Management Authority Decision: Application (HSR02001) Māori, cultural, social and other Note 1. - - Page 6 of 38 Transport and use of treated timber Disposal of the substance Damage to the physical environment from fire - Harm to workers from exposure to fire. Note 3. Note 2. - Note 1: Neither the applicant nor the E&R Report identified any risks to Māori, in relation to section 6(d) especially or more broadly. It was noted that Nga Kaihautu Tikanga Taiao and Runanga were consulted in preparing the reports. The Committee thus concludes that there are negligible risks to Māori. Note 2: The Committee view is that it is evident, without doing a full assessment, that the treated timber poses negligible risk. The volatile components evaporate soon after treatment and the non-volatile components are bound into the timber. Note 3: The risk to people other than workers in the treatment plant is considered to be negligible, without the need for a full assessment Economic Costs and Benefits 4.10 In addition to the costs arising from the risks set out in the table above, the Committee considered that the following economic costs were potentially nonnegligible (see application and E&R Report for more details): Costs of clean up after a spillage, Increased timber treatment costs from use of the substance (from $60/m3 to $120/m3), Costs for additional storage at a treatment facility, Disposal costs. 4.11 The Committee considered that the potentially non-negligible economic benefits were as follows (see application and E&R report for more details): From the ability to export to the USA market and potentially to Australia and Japan, and Easier processing (ease of timber drying, stability of timber). Other Benefits 4.12 The Committee considered that the other (non-economic) potentially non-negligible benefits were as follows (see application and E & R Report for more details): To the environment from the use of a less hazardous product for timber treatment (ie from this substance being used instead of tri butyl tin), To the community (predominately workers) from the use of a less hazardous product (ie from this substance being used instead of tri butyl tin). Environmental Risk Management Authority Decision: Application (HSR02001) Page 7 of 38 Assessment of the Potentially Non- negligible Risks of the Substance 4.13 The risks assessed were those identified above as potentially non-negligible. Risks were assessed in terms of the requirements of clause 12 of the Methodology, including especially the nature of the adverse effects (clause 12(a), the assessment of consequences and probabilities (clause 12(b) and (c)), the impact of uncertainty (clause 12(e) and the impact of risk management (clause 12(d). 4.14 The evidence available was largely scientific in nature and was considered in terms of clause 25(1) of the Methodology. This evidence comprised that provided by the applicant and additional evidence set out in the E&R Report including evidence provided in comments and submissions. Sources of Risk 4.15 In assessing risk the Committee gave particularly consideration to risk arising from the significant hazards of the substance ie flammability, toxicity and eco-toxicity, and examined the extent to which exposure to hazard would be mitigated by controls. Clause 11 dealing with hazards and clause 12 of the Methodology refer. Assessment of Risk to Workers in Treatment Plants from Toxic Effects 4.16 Acute adverse effects on human health could occur from aspiration into the lungs following oral exposure. Aspiration could follow either ingestion or inhalation of the vapours. However, it is considered that as workers will be trained in the hazards (approved handler (12(d))), intentional ingestion of the substance would be very unlikely. The magnitude of the effect would be mild, reversible (the unpleasant solvent taste would put the worker off swallowing fatal amounts intentionally), and only affect the health of 1-2 people at most (minimal) (12(b)). The risk is thus considered to be negligible (12(c)). 4.17 For skin irritation to occur, the worker must come into direct contact with the substance. Workers are required to be trained (approved handler and Health and Safety in Employment (HSE) Act controls) and required to be adequately supervised (HSE) (12(d)). The above controls help prevent the worker's skin from coming in contact with the substance, thus effects are very unlikely to occur. If contact did occur, skin irritation effects are reversible and would only affect a small number of workers, ie those who were exposed, and therefore any effects would be minimal (12(b)). The risk is considered negligible (12(c)). Environmental Risk Management Authority Decision: Application (HSR02001) Page 8 of 38 4.18 Long term exposure of workers to the substance through skin absorption could cause chronic adverse effects such as central nervous system depression, liver, and kidney conditions. Workers are required to be trained (HSNO approved handler and HSE Act controls) and required to be adequately supervised (HSE) (12(d)). The above controls help prevent the worker's skin from coming in contact with the substance. For effects to occur, it would have to be as the result of long term exposure. It is considered that this is very unlikely to occur. The magnitude of effects would be minimal because workers would get irritation effects long before chronic effects occurred and this would encourage them to use personal protective equipment (12(b)). The risk is considered negligible (12(c)). Assessment of Risk to the Aquatic Environment Resulting from Accident Spillage 4.19 The substance is significantly ecotoxic in the aquatic environment. Direct exposure to the substance is likely to kill fish and other aquatic organisms, and in this respect the effects on individual organisms are likely to be severe. However, Protim Optimum is not water soluble and this would limit the effects to a minor level only ie. few organisms affected. 4.20 Spillage could occur either in the course of use in the treatment plant, or as a result of an accident during road transport. Road accidents occur but in the case of transport of liquid materials the frequency is very low and even if accidents occur the likelihood of spillage is only moderate. By definition the effects would be highly localised. Moreover exposure to the aquatic environment would only occur if the accident occurred adjacent to a significant body of water (lake, streams etc). It is concluded that the likelihood of occurrence is very low. In conjunction with minor consequences, it is concluded that the risks are negligible. 4.21 The Committee notes issues raised in submissions relating to contaminated sites and inadequacy of the Department of Labour Approved Code of Practice for the Safe Use of Timber Preservatives and Antisapstain Chemicals. The Committee also notes the applicant's assertion that current treatment processes minimise dripping. 4.22 The Code of Practice is not mandatory but the HSNO controls apply irrespective of whether the Code is followed. The HSNO controls aim to prevent the substance reaching waterways, by requiring secondary containment, appropriate packaging, and emergency response plans. The controls also aim to ensure that only competent workers use it (approved handlers), the use of the substance is accounted for (tracking), the substance is adequately disposed of, and the substance is adequately identified and labelled. Compliance with HSNO is encouraged by the setting of an Environmental Exposure Limit (EEL) and the requirement for a Test Certificate (12(d)). Environmental Risk Management Authority Decision: Application (HSR02001) Page 9 of 38 4.23 With the above controls in place, in particular the packaging and approved handler controls, it is unlikely that the substance will get spilled at the treatment plant. Because of the bunding and emergency management plans, if a spillage occurred, effects would be highly localised, contained within the bunding and not reach a waterway. The likelihood of occurrence of effects is thus considered to be very low (12(b)). The risk is considered to be negligible (12(c)). 4.24 The Committee considers that the need for emergency plans to deal with fires and spills should be a particular focus for enforcement agencies. Assessment of Risk to Valued Terrestial Invertebrates from Accidental Spillage 4.25 Although Protim Optimum is toxic to terrestrial invertebrates such as bees, because of the nature of use (closed system), terrestrial invertebrates would only be exposed as the result of a spillage. The controls to manage accidental spillage are as above (12(d)). Terrestrial invertebrates would have to be directly exposed to the substance for effects to occur. The chances of this occuring are considered unlikely. The exposure would also be highly localised and contained, and would thus only effect a very small number of terrestrial invertebrates (12(b)). The risk is thus considered to be negligible (12(c)). Assessment of Risk to the Physical Environment and to Workers from Fire 4.26 Although Protim Optimum is volatile and flammable its flammability is comparable to that of mineral turpentine. It would require a sustained source of heat to raise the substance above its flash point, as well as an ignition source to ignite. The HSNO controls aim to manage the flammability of the substance at all stages of its lifecycle by setting: Limits on ignition sources (eg spark, temperature), Limits on the proportion of flammable vapour to air (flammable gases and liquids), Controls on the management of locations (transit depots, hazardous atmosphere zones, hazardous substance locations) where flammable substances are being held or used, Controls on containers used to hold certain classes of flammable substances, and Controls on transportation of flammable substances (12(d)). 4.27 The Committee considers that because of the above controls, plus the Test Certificate, approved handler, and packaging requirements, the substance is very unlikely to catch fire. If a fire did occur, the segregation, packaging, test certification, emergency management, and firefighting controls would ensure that the fire wouldn't spread. The effects of the fire would be localised, damage to the physical environment would be readily contained and the effects on people be mild reversible effects such as first degree burns and heat stroke (12(b)). The risk is thus considered to be negligible (12(c)). Environmental Risk Management Authority Decision: Application (HSR02001) Page 10 of 38 Assessment of the Potentially Non-negligible Economic Costs and Benefits 4.28 The Methodology and the Act both call for consideration of monetary and nonmonetary costs (clause 13 and section 9). In addition to the costs arising from the above risks (primarily non-monetary), the following economic costs are considered below: Costs of clean up after a spillage, Increased timber treatment costs from use of the substance (from $60/m3 to $120/m3), Costs for additional storage at a treatment facility, and Disposal costs. 4.29 The Committee agrees with the E&R report that these identified economic costs accrue primarily to the user (monetary clause 13 (a)) although they are likely to be passed on to the wider community through prices. 4.30 The economic benefits of the substance relate principally to its ability to substitute for tri butyl tin, and this particularly applies to exports to the US market. 4.31 The applicant has stated that the use of Protim Optimum is necessary because existing preservative treatments to prevent fungal decay and mould using tri butyl tin compounds are not acceptable for exporting to the USA market. The applicant has identified increased potential earnings of $20 million dollars (monetary). Indirect monetary benefits to the community include increased employment. The benefits of easier processing (ease of timber drying, stability of timber) accrue primarily to the applicant. 4.32 The Committee is unable to place an expected value on the benefits (clause 13(b)) but notes that the applicant has made a business decision that the increased costs of Protim Optimum are out weighed by the increased monetary benefits accruing to the applicant. Assessment of Other Benefits 4.33 The other non-economic benefits are primarily to the environment and to the community (predominantly workers in treatment plants) from the substitutions of Protim Optimum for more hazardous existing treatment chemicals. The principal existing chemical is tri butyl tin. Although tri butyl tin has not been classified under HSNO, the Committee is satisfied that it is more hazardous than Protim Optimum, and that the benefits are legitimate. However, the extent to which the benefit is achieved will depend on the degree of substitution. There is no information available on that point. Environmental Risk Management Authority Decision: Application (HSR02001) Page 11 of 38 Establishment of the Approach to Risk in the Light of Risk Characteristics 4.34 Clause 33 of the Methodology requires the Authority to have regard for the extent to which a specified set of risk characteristics exist when considering applications. The intention of this provision is to provide a route for determining how cautious or risk averse the Authority should be in weighing up risks and costs against benefits. 4.35 The Committee considers that the risks involved in this application are all negligible, therefore the risk characteristics were not further analysed to establish an approach to risk. Variation of Controls under Section 77 4.36 Under section 77(3), (4) & (5) of the Act the default controls determined by the hazard classifications of the substance may be varied. 4.37 The committee agreed with the proposals in the E&R report that the following controls should be deleted (or in effect combined with other controls) as provided for by section 77(5) of the Act. The Committee's view is that the combined controls resulting from these deletions are as sufficient as the full set of default controls, for controlling the adverse effects of the substance. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 Reg 28 Controls for vertebrate poisons. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 Reg 46-48 Restrictions on use of substances in application areas. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 Reg 10, reference to class 9 substances - Restrictions on carriage of ecotoxic substances on passenger service vehicles. Hazardous Substances (Packaging) Regulations 2001 Reg 19 - Packaging requirements for toxic substances (class 6). Hazardous Substances (Packaging) Regulations 2001 Reg 21 - Packaging requirements for ecotoxic substances (class 9). Hazardous Substances (Emergency Management) Regulations 2001 Reg 8(c)(ii) Information requirements for flammable substances Environmental Risk Management Authority Decision: Application (HSR02001) Page 12 of 38 4.38 The Committee noted that the HSNO Regulations relating to Bulk Storage Containers and Tanks Wagons have yet to be made and there are thus no default controls available in this area. The Committee considers that without these regulations, the potential adverse effects are greater than those which would normally be associated with substances of that hazard classification when the full controls framework which supports the classification is available. Therefore the Committee adds controls dealing with bulk storage and tank wagons under section 77(3) of the Act. These controls are listed at the end of the ‘control’ section on page 39. 4.39 The Committee also notes that during the transitional period of the HSNO Act, some premises will be subject to two compliance regimes In the case of Protim Optimum, the HSNO regime would require test certificates as a part of the package of controls. Other substances on the same site would require a dangerous goods licence, but requirements are similar in both cases. 4.40 It would be more sensible to have a single regime in place. Accordingly the Committee considers that if a facility is subject to the Dangerous Goods (Class Three - Flammable Liquids) and the Dangerous Goods (Licensing Fees) Regulations, including the requirement to have a dangerous goods licence, these regulations will apply instead of the Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001. The relevance to dangerous goods licences should lapse once all existing dangerous goods are transferred to the HSNO regime. 4.41 The Committee concluded that the above matter should be addressed by varying the controls under section 77(4)(b) of the Act. In terms of that subsection, the benefits of Protim Optimum (discussed above) will occur to the extent that the substance becomes established in the market, primarily as a substitute for other products. Excessive and unnecessary compliance costs associated with operating overlapping test certifier and dangerous goods regimes are likely to discourage users from using Protim Optimum, and will thus reduce or delay the benefits. The Committee concluded that varying the controls in the manner described above, and as presented in the appended controls, would not significantly increase any adverse effects, and it decided that the controls should be so varied under section 77(4)(b). 4.42 The variations in the controls have been discussed with the applicant, and the provisions of clause 35(b) of the Methodology are effectively met. The controls are thus varied accordingly. Environmental Risk Management Authority Decision: Application (HSR02001) Page 13 of 38 A Recommended but Non-mandatory Control 4.43 As indicated above a potentially significant risk is that to workers in timber treatment plants. Even if this risk is minimal, it would still be prudent to ensure that protective clothing and equipment is used. The Committee was thus of the view that full management of risks would be assisted by imposing the following additional control: Regulation 8 - Protective clothing and equipment Hazardous Substances (classes 6, 8, and 9 Controls) Regulations 2001. 4.44 However, none of the reasons set out in s 77(3) of the Act applies to such an addition. The Committee's conclusion is that the level of control stated in the Regulation is insufficient ie this is possibly a correction which is likely to occur in most cases, and not one applicable only to the substance being considered. The only course of action open to the Committee is thus to strongly recommend the voluntary adoption of this additional measure. 4.45 If similar conclusions are reached in considering other applications in the future this may indicate a need to revise the Regulation so that the requirement for protective clothing applies at a lower classification level. Overall Evaluation of Risks, Costs and Benefits 4.46 Having regard to clauses 22 and 34 of the Methodology and in accordance with clause 26 of the Methodology, risks costs and benefits were evaluated taking account of the proposed controls incorporating proposed variations to the default controls. 4.47 Common units of measurement (clause 34) in effect apply to the combined impact of economic costs and benefits. These are all effectively monetary costs assessable in $ terms. It is reasonable to conclude that the net impact of these costs and benefits is positive, as there would otherwise be no economic incentive for the use of the substance. 4.48 As indicated in the foregoing assessment, individual risks other than those associated with economic costs and benefits (taking into account the controls) are considered to be negligible. The Committee concludes that these risks, and associated costs, are cumulatively negligible. 4.49 Benefits to the environment and to public health derive from this substance being used instead of a more hazardous substance having tri butyl tin as its active ingredient. These benefits are additions to the net economic benefit. 4.50 In accordance with clause 26, where a substance poses negligible risks to the environment and human health and safety, the Authority may approve a substance if it is evident that the benefits associated with that substance outweigh the costs. It is evident in this case that the benefits do outweigh the costs and risks. Environmental Risk Management Authority Decision: Application (HSR02001) Page 14 of 38 Environmental User Charges 4.51 In the current absence of comprehensive criteria for undertaking such a consideration, no consideration has been given to whether or not environmental user charges should be applied to the substance which is the subject of this approval. 5 Decision 5.1 Having considered all the possible risks, costs and benefits of the hazardous substance in accordance with section 29 of the Act, pursuant to clause 26 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 that the substance poses negligible risks to the environment and human health and safety and it is evident that the benefits associated with the substance outweigh the costs. 5.2 In accordance with clause 36(2)(b) of the Methodology, the Committee records that, in reaching this conclusion, it has applied the weighing up tests in section 29 of the Act and clause 26 of the Methodology. 5.3 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 21 - the decision accords with the requirements of the 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 (26 - risks are negligible and costs are outweighed by benefits)/(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. 5.4 The application for importation and manufacture of the hazardous substance Protim Optimum is thus approved, with controls, as detailed in Appendix 1. Mrs Jill White Chair Hazardous Substances Committee Date Environmental Risk Management Authority Decision: Application (HSR02001) Page 15 of 38 Appendix 1 - Controls Applying to the Substance Control Regulation Code F1 Regulation 7 F2 Regulation 8 F3 Regulation 55 F5 Regulations 58-59 Explanation General test certification requirements for all class 1 to 5 substances A test certificate must be issued by an approved test certifier and must typically be renewed yearly. However, the Authority can, on request by the persons required to obtain the test certificate, extend the time period to 3 years. (See also substitute controls at the end of this Appendix) General public transportation restrictions and requirements for all class 1 to 5 substances Other flammable substances are permitted to be carried on passenger service vehicles if the quantity of substance in any individual package is less than that specified in Schedule 1 (Classes 1 to 5 Controls Regulations). (See also substitute controls at the end of this Appendix) General limits on flammable substances Where a class 2, 3 or 4 substance is present at a place for longer than the specified times listed below, and in a quantity that exceeds the levels specified in Table 4 of Schedule 3 (Classes 1 to 5 Controls Regulations), that substance must be held at a hazardous substance location (or transit depot as appropriate). 18 hours if the substance is not subject to tracking requirements 2 hours if the substance is subject to tracking requirements (See also substitute controls at the end of this Appendix) Requirements regarding hazardous atmosphere zones for flammable liquids (3.1) There is a requirement to establish a hazardous atmosphere zone wherever class 3.1C substances are present in quantities greater than those specified in Table 3 of Schedule 3 (Classes 1 to 5 Controls Regulations). The zone must comply with either of the standards as listed in regulation 58 (a)-(b) or an ERMA approved code of practice. There are a number of requirements that must be met regarding hazardous atmosphere zones, including: any controls placed on electrical systems or electrical equipment within a hazardous atmosphere zone must be consistent with any controls on electrical systems or electrical equipment set under other legislation that are relevant to that specific location. This is to ensure that any potential ignition sources from electrical system or electrical equipment are protected or insulated to an extent that is consistent with the degree of hazard [Regulation 59]. test certification requirements [Regulation 81]. Environmental Risk Management Authority Decision: Application (HSR02001) Page 16 of 38 Control Regulation Code F6 F11 Regulations 60-70 Regulation 76 Explanation (See also substitute controls at the end of this Appendix) Requirements to prevent unintended ignition of flammable gases (2.1.1) aerosols (2.1.2) and liquids (3.1) These regulations prescribe controls to reduce the likelihood of unintended ignition of flammable gases, aerosols and liquids. Controls are prescribed with the aim of covering all foreseeable circumstances in which unintended ignition could take place, and include: placing limits on the proportion of flammable vapour to air to ensure that the proportion of flammable vapour to air will always be sufficiently outside the flammable range, so that ignition cannot take place, and ensuring that there is insufficient energy available for ignition. This energy could be in the form of either temperature or ignition energy (eg a spark). Accordingly, the controls provide two approaches to ensure that there is insufficient energy for ignition: (1) keeping the temperature of the substance, or the temperature of any surface in contact with the substance, below 80% of the auto-ignition temperature of the substance, and (2) keeping sources of ignition below the minimum ignition energy, either by removal of the ignition source from any location where flammable substances are handled, or by protecting the “general” mass of flammable material from the ignition source, eg by enclosing any ignition sources in an enclosure that will not allow the propagation of the flame to the outside; or using flameproof motors especially designed to prevent ignition energy escaping. It should be noted that any person handling any quantity of a class 3.1 substance under any of regulations 61, 63(4), 65, 67 and 69 must be an approved handler for that substance, ie the trigger quantities that typically activate approved handler requirements do not apply [Reg 60(2)]. (See also substitute controls at the end of this Appendix) Segregation of incompatible substances In order to reduce the likelihood of unintended ignition of flammable substances, there is a requirement to ensure that the substance does not come into contact with any incompatible substance or material, eg by keeping class 4.2 substances away from air and by keeping class 4.3 substances away from water. 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). (See also substitute controls at the end of this Appendix) Environmental Risk Management Authority Decision: Application (HSR02001) Page 17 of 38 F12 Regulations 77-78 General requirement for hazardous substance locations for flammable substances There is a requirement to establish a hazardous substance location where any class 2, 3 or 4 substance is present in quantities greater than those specified in Table 4 of Schedule 3 (Classes 1 to 5 Controls Regulations) and for a period exceeding either 18 hours (for substances that do not require tracking) or 2 hours (for substances that are subject to the Tracking Regulations). Within such zones, there is a requirement for the person in charge to: notify the responsible enforcement authority of the locality and capacity of the hazardous substance location where relevant, ensure that the substances will be under the control of an approved handler and that any container/building used to hold the substances is secured ensure that any test certification requirements are met ensure that a site plan is available for inspection where required, establish and mange a hazardous atmosphere zone F14 Regulation 81 A number of controls are prescribed for hazardous substance locations in order to reduce the likelihood of unintended ignition of class 2, 3 or 4 substances [Reg 78], including: requirements for fire resistant walls (240/240/240 minutes) and separation distances (greater than 3 m) to isolate any ignition sources safety requirements for electrical equipment (construction, design, earthing) requirements for segregation of incompatible substances (See also substitute controls at the end of this Appendix) Test certification requirements for facilities where class 2.1.1, 2.1.2 or 3.1 substances are present There is a test certification requirement when class 3.1 substances are present at any hazardous substance location, hazardous atmosphere zone or transit depot when in quantities above the amounts specified in Tables 3 and 4 of Schedule 3, (Classes 1 to 5 Controls Regulations). That test certificate must be issued by an approved test certifier and must demonstrate compliance with a number of specified controls, including: notification to relevant enforcement officer of hazardous substance location approved handler requirements security requirements Environmental Risk Management Authority Decision: Application (HSR02001) Page 18 of 38 F16 F17 Regulation 83 Regulations 84-85 hazardous atmosphere zone requirements, including controls on electrical systems and electrical equipment segregation of incompatible substances signage requirements emergency management requirements fire-fighting equipment secondary containment (See also substitute controls at the end of this Appendix) Controls on transit depots where flammable substances are present Transit depots are places designed to hold hazardous substances (in containers that remain unopened) for a period of up to 3 days, but for periods that are more than: 18 hours (for substances that do not require tracking) or 2 hours (for substances that are subject to the Tracking Regulations) Whenever any class 2, 3 or 4 substance is held at a transit depot in quantities exceeding the levels specified in Table 4 of Schedule 3 (Classes 1 to 5 Controls Regulations), there is a requirement for the person in charge to: notify the responsible enforcement authority of the locality and capacity of the hazardous substance location where relevant, ensure that the substances will be under the control of an approved handler ensure that any road vehicle loaded with containers of class 2, 3 or 4 substances is within specified distances of other vehicles or places containing hazardous substances ensure that containers of class 2, 3 or 4 substances held in the depot (but not loaded onto a vehicle) are within specified distances from vehicles or other containers ensure that all class 2, 3 or 4 substances remain in their containers and the containers remain closed ensure the safety of any electrical equipment comply with any signage requirements comply with relevant parts of other Acts and Regulations, eg Electricity Act 1992, HSE (Mining Underground Regulations) 1999 or Civil Aviation Rules (See also substitute controls at the end of this Appendix) Requirements to control adverse effects of intended ignition of flammable substances, including requirements for protective equipment and clothing These controls are intended to ensure that where any class 2, 3 or 4 substance is intentionally burnt, the effects of combustion are managed: to ensure that adverse effects are contained within the intended area, and Environmental Risk Management Authority Decision: Application (HSR02001) Page 19 of 38 T1 to prevent people being exposed to harmful levels of heat radiation. Reg 84(1) prescribes controls relating to the maximum level of heat radiation that a person may be exposed to whenever a class 2, 3 or 4 substance is intentionally burnt. If the intended combustion involves burning substances at a rate in excess of 20 kg/hour or 20 L/hour, there is an additional requirement for the person in charge to establish a combustion zone around the intended combustion area [Reg 84(2)]. The person in charge of the combustion zone must ensure that: the enforcement officer has been notified of the combustion zone’s location the combustion zone encompasses all areas where there is the potential for people to be exposed to a higher degree of heat radiation than the level specified in reg 84 (1)(b) a site plan of the combustion zone is available at all times all non-authorised personnel are excluded from the combustion zone the level of heat radiation outside the combustion zone at no time exceeds the level specified in reg 84 (1)(b) there is appropriate signage around the perimeter of the zone warning that combustion is occurring and prohibiting entry into the zone. For those situations where the level of heat radiation within a combustion zone may exceed the level specified in reg 84 (1)(b), there is a requirement for the person in charge to ensure that all people entering the combustion zone have the appropriate protective clothing and equipment [Reg 85]. Specific requirements are prescribed relating to the design, construction and use of the protective clothing and equipment, including: they must be designed, constructed and operated to prevent any person being subjected to more than the level of heat radiation specified in reg 84 (1)(b) they must either be constructed of materials that are not degraded, attacked or combusted by the substance under the expected use conditions, or if they are not completely resistant, they must retain their integrity for the time specified by the supplier. they must be accompanied by documentation that gives sufficient instruction on their use and maintenance. (See also substitute controls at the end of this Appendix) Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 – Toxic Property Controls Regulations Limiting exposure to toxic substances 11-27 This control relates to limiting people’s exposure to toxic substances through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived Environmental Risk Management Authority Decision: Application (HSR02001) Page 20 of 38 from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: It is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested It is a substance to which people are likely to be exposed to during their lifetime, and; Exposure is likely to result in an appreciable toxic effect T2 Regulations 29, 30 T4 Regulation 7 T5 Regulation 8 T7 Regulation 10 No TEL is set for this substance. Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and only applies to places of work that the public does not have access to. The Department of Labour WES for white spirits of 100ppm or 525 mg/m3 is adopted. Requirements for equipment used to handle substances Any equipment used to handle toxic substances (eg spray equipment) must retain and/or dispense the substance in the manner intended, ie without leakage, and must be accompanied by sufficient information so that this can be achieved. Requirements for protective clothing and equipment Protective clothing/equipment must be employed when substances that are highly toxic or corrosive are being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with the substance and is not directly exposed to a concentration of the substances that is greater than the WES for that substance. The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing or equipment may be used, and the requirements for maintaining the clothing/equipment. 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 toxic or corrosive substances on public transport vehicles: carriage of any quantity of a class 6.1A or 8.2A substances is prohibited; Environmental Risk Management Authority Decision: Application (HSR02001) Page 21 of 38 carriage of any other class 6 or 8 substance is restricted to the quantities per package provided in Schedule 2 of the classes 6. 8 and 9 Control Regulations. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 – Ecotoxic Property Controls E1 Regulations 32 – 45 E3 Regulation 49 E5 Regulations 5, 6 E6 Regulation 7 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 sedimant or water), including deposition of a substance onto surfaces (eg as in spray drift deposition). The default EEL of 0.0001mg/L is set for this substance. Controls relating to protection of terrestrial invertebrates eg beneficial insects This regulation applies to substances that are ecotoxic to terrestrial invertebrates (class 9.4 substances) and prescribes controls to restrict the use of such substances in situations where they may poses a high risk to beneficial invertebrates eg honeybees. Specifically, a person must not apply a class 9.4 substance: in an area where bees are foraging and the substance is in a form in which bees are likely to be exposed to it; or on specific plants likely to be visited by bees if the plant is in open flower or part bloom, or is likely to flower within a specified period of time following application of the substance (not longer than 10 days). Requirements for keeping records of use A person using a substance that is highly ecotoxic (ie has a hazard classification of 9.1A, 9.2A, 9.3A, or 9.4A) must keep a written record of that use if 3kg or more of the substance is applied or discharged within 24 hours in an area where the substance may enter air or water (and leave the place where it is under control). The information to be provided in the record is described in regulation 6(1). The record must be kept for a minimum of 3 years following the use and must be made available to an enforcement officer on request. Requirements for equipment used to handle substances Any equipment used to handle ecotoxic substances (eg spray equipment) must retain and/or dispense the substance in the manner intended, ie without leakage, and must be accompanied by sufficient information so that this can be achieved. Environmental Risk Management Authority Decision: Application (HSR02001) Page 22 of 38 E7 Regulation 9 E8 Regulation 10 Cod e --------I1 Approved handler requirements Where ecotoxic substances of any hazard classification 9.1A, 9.2A, 9.3A or 9.4A are held in any quantity, the substances must generally be under the personal control of an approved handler at all times, or locked up. However, such substances may be handled by a person who is not an approved handler if: an approved handler is present at the facility where the substance is being handled, and the approved handler has provided guidance to the person in respect of handling, and the approved handler is available at all times to provide assistance if necessary Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for environmental exposure to ecotoxic substances, the carriage of any class 9 substance on public transport vehicles is restricted to either 5L, 5 kg or 1000 mL gas (aggregate water capacity). Hazardous Substances (Identification) Regulations 2001 ----------------Regulations 6, 7, 32-35, 36 (1)-(7) 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 places where there is large quantities of the substance. ---------------------------------------------------------------------------------------------------------------------------------------General identification requirements These controls relate to the duties of suppliers and persons in charge of hazardous substances with respect to identification (essentially labelling) (regs 6 and 7), accessibility of the required information (regs 32 and 33) and presentation of the required information with respect to comprehensibility, clarity and durability (regs 34, 35, 36(1)-(7)). Regulation 6 – Identification duties of suppliers Suppliers of any hazardous substance must ensure it is labelled as required by regulations 9 and 14 (priority identifiers for ecotoxic and toxic substances), and regulations 18, 20 and 25 (secondary identifiers for ecotoxic and toxic substances) of the Identification regulations (see below) before supplying it to any other person. Suppliers must also ensure that there is no information supplied with the substance (or its packaging) that suggests it has hazardous properties that it does not have. Environmental Risk Management Authority Decision: Application (HSR02001) Page 23 of 38 I3 I5 Regulation 9 Regulation 11 Regulation 7 – Identification duties of persons in charge Persons in charge of hazardous substances must ensure that the hazardous substances are identified with all relevant priority identifier information (as required by regs 8 - 17) and secondary identifier information (as required by regs 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 2 seconds (reg 32), and the secondary identifier information available within 10 seconds (reg 33). Persons in charge must also ensure that the substance is not identified as belonging to a hazard class that it does not belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by regs 8 - 17) must be available within 2 seconds, eg. on the label All secondary identifier Information (as required by regs 18 - 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 all required information must continue 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 ecotoxic substances must be prominently identified as being ecotoxic. This information must be available to any person handling the substance within two seconds (reg 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for flammable substances This requirement specifies that flammable substances must be prominently identified as being flammable. In addition, the following information must be provided: an indication of whether the substance is a gas, aerosol, liquid or solid if a flammable liquid, information must be provided on its general degree of hazard (eg highly flammable) Environmental Risk Management Authority Decision: Application (HSR02001) Page 24 of 38 I8 Regulation 14 I9 Regulation 18 I11 Regulation 20 if a flammable solid, information must be provided on its general type of hazard (eg dangerous when wet) This information must be available to any person handling the substance within two seconds (reg. 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for toxic substances This requirement specifies that toxic substances must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance (eg. highly poisonous), and the need to restrict access to children. This information must be available to any person handling the substance within two seconds (reg 32) and can be provided by way of signal headings or commonly understood pictograms on the label Secondary identifiers for all hazardous substance This control relates to detail required for hazardous substances on the product label. This information must be accessible within 10 seconds (reg. 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. 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, a description of each likely change and the date by which it is likely to occur. Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for ecotoxic substances. This information must be accessible within 10 seconds (reg. 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 a ecotoxic substance of classification 9.1A, an indication of its general type and degree of hazard (eg very toxic to aquatic life) in the case of a ecotoxic substance of classification 9.4B, an indication of its general type of hazard (eg ecotoxic to terrestrial invertebrates) Environmental Risk Management Authority Decision: Application (HSR02001) Page 25 of 38 I13 Regulation 22 I16 Regulation 25 I17 Regulation 26 These requirements could be addressed by statements on the label with respect to its action against both target and non-target organisms and the method of application used to avoid exposure to non-target organisms. A statement should be included warning against incorrect disposal in sensitive environments. Secondary identifiers for flammable substances This control relates to the additional label detail required for flammable substances. This information must be accessible within 10 seconds (reg. 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 highly flammable liquid) an indication of the circumstances in which it may be ignited unintentionally an indication of the likely effect of an unintentional ignition an indication of the steps to be taken to prevent an unintentional ignition Secondary identifiers for toxic substances This control relates to the additional label detail required for toxic substances. This information must be accessible within 10 seconds (reg. 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of toxic hazard (eg mild skin irritant) an indication of the circumstances in which it may harm human beings an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm an indication of the steps to be taken to prevent harm to human beings the name and concentration of any ingredient that would independently of any other ingredient, cause the substance to be classified as a class 6.9. 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 regulations 19(f) and 25 (e) and (f). [Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the product label, the name and concentration of any ingredient that would independently of any other ingredient, cause the substance to be classified as 6.9]. Environmental Risk Management Authority Decision: Application (HSR02001) Page 26 of 38 I18 Regulation 27 Requirements for using concentration ranges This control provides the option of providing concentration ranges for those ingredients whose concentrations are required to be stated on the product label as specified by regulations 19(f) and 25 (e) and (f). [Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the product label, the name and concentration of any ingredient that would independently of any other ingredient, cause the substance to be classified as either 6.9]. I19 Regulations 29 – 31 Alternative information in certain cases Regulation 29 relates to alternative ways of presenting the priority and secondary identifier information required by regulations 8 – 25 when substances are contained in fixed bulk containers or bulk transport containers. The information requirements for fixed bulk containers are specified in reg 29 (1). The information requirements for bulk transport containers are specified in reg 29 (2), which essentially state that it is sufficient compliance for HSNO if the substance is labelled or marked in compliance with the requirements of either the Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. Regulation 30 relates to situations when hazardous substances are in multiple packaging and the outer packaging obscures some or all of the required substance information. The outer packaging must : be clearly labelled with all relevant priority identifier information ie the hazardous properties of the substance must be identified, or be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant, or in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background), or bear the relevant class label assigned by the UN Model Regulations Regulation 31 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 form 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. Environmental Risk Management Authority Decision: Application (HSR02001) Page 27 of 38 I21 Regulations Documentation required in places of work 37–39, 47–50 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) (regs 37, 38 and 50); the general content requirements of the documentation (reg 39 and 47); the accessibility and presentation of the required documentation in respect of comprehensibility and clarity (reg 48). These controls are triggered when substances of specific hazard classifications are held in the workplace in quantities exceeding the levels as specified in Schedule 2 of the Identification Regulations. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by regulations 39 – 46 when selling or supplying to another person a quantity of a hazardous substance at or above the level specified in Schedule 2 for that classification, 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 above those specified in reg 38 (and with reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation containing all relevant information required by regulations 39 – 46. The person in charge must also ensure that the documentation does not contain any information that suggests the substance has hazardous properties it does not have. 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 Environmental Risk Management Authority Decision: Application (HSR02001) Page 28 of 38 the date on which the documentation was prepared the name and concentration of any ingredients that would independently of any other ingredient, cause the substance to be classified as either a class 6.1A, 6.1B, 6.1C, 6.5, 6.6, 6.7, 6.8,6.9, 8.2 or 8.3. 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. I23 Regulation 41 I25 Regulation 43 Specific documentation requirements for ecotoxic substances The documentation provided with ecotoxic substances must include the following information: 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 Specific documentation requirements for flammable substances The documentation provided with flammable substances must include the following information: its general degree and type of hazard a full description of the circumstances in which it may be ignited unintentionally the likely effect of an unintentional ignition a full description of the steps to be taken to prevent an unintentional ignition if it is a gas, its lower and upper explosive limits, expressed as volume percentages in air if it is a liquid, its lower and upper explosive limits, expressed as volume percentages in air or its flash point Environmental Risk Management Authority Decision: Application (HSR02001) Page 29 of 38 I28 Regulation 46 I29 Regulations 51 – 52 (and flash point methodology) and auto-ignition temperature. If it is a self-reactive solid, its self-acceleration decomposition temperature and heat of decomposition per unit mass. Specific documentation requirements for toxic substances The documentation provided with toxic substances 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 is a gas or an aerosol, its vapour pressure, and the temperature at which that pressure was measured 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 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 in respect of signage These controls specify the requirements for signage, in terms of content, presentation and positioning at places where hazardous substances are held in quantities exceeding those specified in Schedule 3 of the Identification Regulations. Where a substance triggers more than one hazard classification, the most stringent quantity applies. 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 and degree of hazard of the substance (eg highly flammable) Environmental Risk Management Authority Decision: Application (HSR02001) Page 30 of 38 I30 Cod e P1 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). Regulation 53 Advertising corrosive and toxic substances Any advertisements for a class 6 substance must provide information identifying that it is toxic, specify the degree of toxicity and the need to restrict access by children. Hazardous Substances (Packaging) Regulations 2001 Regulations 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 are 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 3 (Packaging Regulations) 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 – 21. Regulation 8 – Compatibility Hazardous substances must not be packed in packaging that has been previously packed with substances with which it is incompatible. Environmental Risk Management Authority Decision: Application (HSR02001) Page 31 of 38 P3 Regulation 9 P5 Regulation 11 PG3 Cod e D2 Requirement for substances packed in limited quantities Hazardous substances with a hazard classification in column 1 of Schedule 5 may be packaged in packaging that complies with the tests set out in Schedule 4. Packaging requirements for flammable liquids (subclass 3.1) The packaging requirements for flammable liquids are as follows: 3.1C substances in quantities over 5 L should be packaged according to Schedule 3 (UNPG III), but may be packaged according to Schedule 4 when in quantities below 5 L. There is an additional provision that packages containing less than 0.5 L (500 mL) of a class 3.1C substance do not have to comply with the drop test performance standard contained in Schedule 4 providing there is a warning statement on the outside of the package that the package may not withstand a drop of 0.5 m. In addition, viscous substances of hazard classification 3.1C are exempt from the packaging requirements that would otherwise apply, and can be packaged according to Schedule 4. Schedule 3 This schedule provides the test methods for packaging that is required to be tested accordance with this schedule. The tests correlate to packaging requirements equivalent to UN Packaging Group III Hazardous Substances (Disposal) Regulations 2001 Regulation 6 Disposal requirements for flammable substances Flammable (class 2, 3 and 4) substances 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 flammable gases (class 2.1.1), aerosols (class 2.1.2) liquids (class 3.1) and readily combustible solids (class 4.1.1) 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 Environmental Risk Management Authority Decision: Application (HSR02001) Page 32 of 38 requirements for this are set out in regulation 6 (3)(b) of the Disposal Regulations. D4 Regulation 8 D5 Regulation 9 D6 Regulation 10 D7 Regulations 11, 12 Disposal requirements for toxic and corrosive substances A class 6 or 8 substance 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) set by the Authority for that substance, or exporting the substance from New Zealand as a hazardous waste Disposal requirements for ecotoxic substances A class 9 substance 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 Disposal requirements for packages This control gives the disposal requirements for packages that contained a hazardous substance 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. 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 a hazardous substance that exceeds the trigger levels as specified in Schedule 1 of the disposal regulations. 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 Environmental Risk Management Authority Decision: Application (HSR02001) Page 33 of 38 D8 Cod e EM1 as described in Regs 34-36 of the Identification regulations (code I1). Regulations Documentation requirements 13, 14 These controls relate to the provision of documentation concerning disposal (essentially in a MSDS) that must be provided when selling or supplying a quantity of a hazardous substance that exceeds the trigger levels as specified in Schedule 2 of the disposal regulations. 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 Regs 48 (2), (3) and (4) of the Identification regulations (code I21). Hazardous Substances (Emergency Management) Regulations 2001 Regulations 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 any hazardous substance when present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management Regulations. 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)). EM4 Regulation 8(c) EM6 Regulation 8(e) Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. Additional information requirements for flammable substances The following information must be provided with flammable substances when present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management Regulations. A description of the material and equipment needed to put out a fire involving it. Information requirements for toxic substances The following information must be provided when a toxic substance of class 6.1, or 6.3 is present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management Regulations. A description of the usual symptoms of exposure Environmental Risk Management Authority Decision: Application (HSR02001) Page 34 of 38 A description of the first aid to be given to a person exposed to it A 24-hour emergency service telephone number EM7 Regulation 8(f) Information requirements for ecotoxic substances The following information must be provided with ecotoxic substances when present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management Regulations. 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 EM8 Regulations Level 2 emergency management information requirements 12–16, 18–20 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 Material Safety Data Sheets) that must be provided where hazardous substances are sold or supplied, or held in a workplace, in quantities equal to or greater than the quantities specified in Schedule 2 (Emergency Management Regulations). 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 Regulation 17 Regulation 18 provides accessibility requirements (documentation to be available within 5 minutes) and regulation 19 provides requirements for presentation with respect to comprehensibility and clarity. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Extra content for flammable and oxidising substances and organic peroxides There is an additional requirement for flammable and oxidising substances and organic peroxides 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. Environmental Risk Management Authority Decision: Application (HSR02001) Page 35 of 38 EM10 EM11 EM12 Regulations 21 – 24 Regulations 25 – 34 Regulations 35 – 41 Fire extinguishers Every place (including vehicles) where explosive, flammable or oxidising substances are held in a place of work in quantities exceeding those specified in Schedule 3 (Emergency Management Regulations) must have the specified number of fire extinguishers (either one or two as detailed in Schedule 3) [Reg 21]. The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching hazardous substances, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of hazardous substances Each fire extinguisher must be located within 30 m of the substance, or, in a transportation situation, in or on the vehicle [Reg 22]. The performance measure for an extinguisher is that it must be capable of extinguishing a fully ignited pool of flammable liquid (50 mm deep and at least 6 m2 in area), before the extinguisher is exhausted, and when used by one person [Reg 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 hazardous substances are held (or reasonably likely to be held on occasion) in quantities equal to or greater than those specified in Schedule 4 (Emergency Management Regulations). 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 – 30. Requirements relating to the availability of equipment, materials and people are provided in regulation 31, requirements regarding the availability of the plan is 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 above those specified in Schedule 4 of the Emergency Management Regulations. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60 L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60 L and 450 L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than Environmental Risk Management Authority Decision: Application (HSR02001) Page 36 of 38 EM13 Regulation 42 450 L. Regulation 40 prescribes requirements for places where hazardous substances are held under ground. 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 These controls relates to the provision of emergency management information on signage at places where hazardous substances are held at quantities equal to or greater than the quantities specified in Schedule 5. 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. Code AH1 Hazardous Substances (Personnel Qualification) Regulations 2001 Regulations 4–6 Approved Handler requirements (including test certificate and qualification requirements) Some (highly) hazardous substances are required to be under the control of an approved handler during specified parts of the lifecycle. An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances. The specific classes and quantities of hazardous substances that trigger approved handler requirements are listed in the schedules of the relevant property controls regulations (Classes 1 to 5 Controls Regulations and Classes 6, 8 and 9 Controls Regulations). 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. Code TR1 Hazardous Substances (Tracking) Regulations 2001 Regulations 4(1), 5, 6 General tracking requirements Some (highly) hazardous substances are subject to tracking requirements ie the location and movement of the substance must be recorded at each stage of its lifecycle until its final disposal. The hazard classifications of the substances requiring tracking are listed in Schedule 1 of the Tracking Regulations. The type of information to be Environmental Risk Management Authority Decision: Application (HSR02001) Page 37 of 38 recorded is specified in Schedule 2 of the Tracking Regulations and includes a requirement to identity the approved handler and provision of information on the identification, quantity, location and disposal of the substance. The record must meet the location and presentation requirements specified in Part 2 of the Identification Regulations ie it must be accessible within 10 minutes and meet the performance standards for comprehensibility and clarity. The record must be kept for a period of 12 months after the substance has been transferred to someone else. If substance is discharged into the environment or disposed of, the record must be kept for 3 years. Regulation 6 provides requirements for the transfer of hazardous substances from one place to another. Code Dangerous Goods Regulations Substitute Control Until such time as the HSNO Tank Wagon Regulations come into force, the provisions of the Dangerous Goods Regulations relating to the transportation of flammable liquids in tank wagons must be complied with. Until such time as the HSNO Bulk Storage Tanks Regulations come into force, the provisions of the Dangerous Goods Regulations relating to the storage of flammable liquids in bulk must be complied with. If the substance is kept at a facility already subject to the Dangerous Goods (Class Three – Flammable Liquids) and the Dangerous Goods (Licensing Fees) Regulations, including the requirement to have a dangerous goods licence, these regulations apply in place of the requirement to obtain a test certificate under control F1-F17 (above) until the class three flammable liquids are deemed assessed and approved by regulations under section 160(1)(a) of the HSNO Act. Environmental Risk Management Authority Decision: Application (HSR02001) Page 38 of 38