ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 10 July 2006 Application code HSR06047 Application type To import or manufacture any hazardous substance under Section 28A(2)(a) of the Hazardous Substances and New Organisms (HSNO) Act 1996 Applicant Mattersmiths Holdings Ltd PO Box 156 Westpark Marina AUCKLAND Applicant contact: Paul Maynard Purpose Blue Preserve Type DC: to import or manufacture as a wood preservative applied at industrial treatment plants (rapid similar) Date received 3 May 2006 Consideration date 7 July 2006 Considered by Rob Forlong (Chief Executive, ERMA New Zealand) 1 Summary of Decision 1.1 The application to import or manufacture Blue Preserve Type DC is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology), based on its similar composition and similar hazardous properties to a substance that has been approved by the Authority. 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: Blue Preserve Type DC 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 this substance: Main Category: Industrial category: Function/Use category: 3 0 39 Non-Dispersive Use Other Pesticides, non agricultural Subcategory: preservative products 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 28A(2)(a), taking into account 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 purpose of the application is to import or manufacture Blue Preserve Type DC as a timber treatment chemical. 3.2 The application was formally received on 3 May 2006. 3.3 The Ministry of Health and the Department of Labour Workplace Group were advised of the application (clause 2(2)(e)). 3.4 No responses were received. 3.5 Project Team: Margaret Keane Applications Advisor (Hazardous Substances) Laura Docker Science Advisor (Hazardous Substances) Report review and sign-out by: Dr Robin Toy 4 Science Team Leader (Hazardous Substances) Consideration Sequence of the Consideration 4.1 Mattersmiths Holdings Ltd seeks approval under section 28A(2)(a) of the HSNO Act to import or manufacture Blue Preserve Type DC. 4.2 Under section 28A(2)(a), an application can be assessed under rapid assessment procedures if it can be shown that a substance having a similar composition and similar hazardous properties has been approved by the Authority. Decision-making authority for such rapid assessments has been delegated to the Chief Executive of ERMA New Zealand (section 19(2)(d)). 4.3 The approach adopted when considering this application was: to identify the composition and hazardous properties of the proposed substance, Blue Preserve Type DC, and of the “reference” similar substance provided by Mattersmiths Holdings Ltd and other potential reference substances; Environmental Risk Management Authority Decision: Application HSR06047 Page 2 of 22 to determine whether Blue Preserve Type DC has a similar composition and similar hazardous properties to the reference substance nominated or another reference substance. 4.4 And then: to determine whether Blue Preserve Type DC has a similar life-cycle to the reference substance; to consider whether the risks posed by Blue Preserve Type DC are the same as, less than or greater than those posed by the reference substance; to consider whether there are any other effects which mean that Blue Preserve Type DC should not be rapidly assessed; and to consider whether the controls that apply under the HSNO Act to the reference substance are applicable to Blue Preserve Type DC. Information Review 4.5 I have reviewed the information supplied by Mattersmiths Holdings Ltd and consider that the information constitutes an adequate and appropriate basis for considering the application (clause 8). There are no significant uncertainties (i.e. sufficient to influence decision making) in the scientific and technical information relating to the risks of the substance (clauses 29 and 30). Composition of Blue Preserve Type DC relative to that of the reference substance 4.6 Mattersmiths Holdings Ltd identified a reference substance against which Blue Preserve Type DC should be compared as a timber treatment which was approved with controls under the HSNO Act on 22 July 2005 and given the ERMA Approval Code HSR001674. 4.7 Both Blue Preserve Type DC and the reference substance contain the active ingredients copper (II) ion as a copper complex and a didecyldimethylammonium compound as a concentrated solution. The didecyldimethylammonium salt in Blue Preserve Type DC differs from that in the reference substance and there are minor differences between the excipients of the formulations. However, these differences do not affect the hazard profiles. I also note that the concentration of major hazardous components in Blue Preserve Type DC is less than that in the reference substance. 4.8 Both Blue Preserve Type DC and the reference substance are soluble concentrates. 4.9 After taking the variations in composition into account, I have concluded that the compositions of Blue Preserve Type DC and the reference substance are of the same nature and kind. Therefore, I am satisfied that Blue Preserve Type DC has a similar composition to the reference substance. Hazardous Properties of Blue Preserve Type DC relative to the Reference Substance 4.10 Mattersmiths Holdings Ltd has provided information related to the hazardous properties of Blue Preserve Type DC. 4.11 To be eligible for consideration under section 28A(2)(a), Blue Preserve Type DC must have similar hazardous properties to the reference substance. The hazardous properties of Blue Preserve Type DC and the reference substance are listed below: Environmental Risk Management Authority Decision: Application HSR06047 Page 3 of 22 Hazard Endpoint Acute toxicity Respiratory sensitisation Contact sensitisation Developmental toxicity Target organ systemic toxicity Corrosivity to metals Skin corrosivity Eye corrosivity Aquatic ecotoxicity Terrestrial vertebrate ecotoxicity 4.12 Blue Preserve Type DC 6.1E 6.8B 6.9B 8.2C 8.3A 9.1A 9.3C Reference Substance 6.1D 6.5A 6.5B 6.8B 6.9B 8.1A 8.2C 8.3A 9.1A 9.3C The hazard profile of Blue Preserve Type DC is less than that of the reference substance in terms of it not being classed as a respiratory or contact sensitiser (6.5A, 6.5B) and it is not classed as being corrosive to metals (8.1A). Evaluation against the Criteria for Similar Composition and Similar Hazardous Properties 4.13 I consider that, based on the application submitted by Mattersmiths Holdings Ltd, and on information available on the reference substance, the analysis in the preceding paragraphs shows that the criteria for similar composition and similar hazardous properties under section 28A(2)(a) have been met. Part II Matters (Non Scientific Considerations) 4.14 No information has arisen during the consideration of this application that has caused me to believe that the substance, with controls in place, could result in significant effects on: the sustainability of native and valued introduced flora and fauna; the intrinsic value of ecosystems; public health; the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga; the economic and related benefits to be derived from the use of Blue Preserve Type DC; New Zealand’s international obligations. 5 Life-cycle, Risks and Controls Purpose of use 5.1 Blue Preserve Type DC is a water soluble mixture of a copper complex and quaternary ammonium compound and is to be applied following dilution in water in industrial timber treatment plants. The proposed use for Blue Preserve Type DC is the same as that for the reference substance, namely wood preservation. Blue Preserve Type DC is to be used to impregnate sawn timber or wood products to prevent degradation by fungi, wood boring insects and termites. The active ingredients remain in the wood to provide long term protection from insects, termites and wood degrading fungi. Environmental Risk Management Authority Decision: Application HSR06047 Page 4 of 22 5.2 Blue Preserve Type DC would be supplied for use only by industrial timber treatment facilities. It is not a consumer product for retail outlets. 5.3 Wood treated with Blue Preserve Type DC could be used within New Zealand for applications with hazard rating classes H1 to H5. Accordingly, Blue Preserve Type DC treated could be used in a wide range of areas from the protection of house framing through to the treatment of decks and playground equipment. It could also be used on fences, posts and poles in agricultural or horticultural applications. Manufacture 5.4 Manufacture of the product will be the same as that for the reference substance, namely preparation of an alkaline copper ammine solution followed by the blending of this with the quaternary ammonium compound. The blending ratio is determined by wood preservative specifications, which require a CuO:quat ratio of 2:1. 5.5 The substance will be manufactured as a concentrate that is then diluted (with water) at the timber treatment site to the appropriate working strength solution (normally 0.5% m/v to 2.0% m/v total actives depending on the concentration required in the timber). It will only be used in industrial timber treatment plants. Blue Preserve Type DC will be manufactured as a concentrate to reduce transportation costs. 5.6 Manufacture will be in purpose designed and operated equipment at a site approved for the manufacture, storage and handling of hazardous chemicals used in the timber industry. New Zealand treatment plants operate to meet the requirements of the OSH Code of Practice for the Safe Use of Timber Preservatives and Antisapstain Chemicals and any additional local Council requirements or from other legislation/regulations (e.g. the Resource Management Act 1991). Transport, Storage and Use 5.7 Blue Preserve Type DC will be transported in UN approved drums (HDPE or lined steel drums) or in Intermediate Bulk Containers (IBCs) or in purpose designed bulk tankers. Storage will be in secure areas with limited access to the general public. 5.8 Drums, IBCs and bulk tankers will carry a product label identifying the product, ingredients, priority identifiers (hazard classifications), warning and first aid information, manufacturer and contact details. In addition, the applicant has stated that a Safety Data sheet will be available for the preservative (e.g. for the treatment company) and for the treated timber (e.g. for treatment company, merchants, builders, users). 5.9 The timber preservative concentrate will be manufactured in New Zealand and transported off-site in 1,000 L IBCs or 200 L drums or by bulk tanker. 5.10 Transport within New Zealand will be via road transport operators approved to handle products classified as corrosive, ecotoxic and toxic. Although it is unlikely tanks will rupture or leak there is potential risk of a spillage in the event of a traffic accident. Under such circumstances site management would be by the emergency services (police, fire) to contain the spill and oversee the recovery of liquid and clean up. 5.11 Packaging will be labelled with priority hazard identifiers and other information as required under the HSNO regulations and can be recycled. The manufacturing site is already approved to manufacture similar products. Environmental Risk Management Authority Decision: Application HSR06047 Page 5 of 22 5.12 The Blue Preserve Type DC active ingredients are impregnated in the timber in the treatment process and as the timber dries the active ingredients remain deposited in the timber. This type of preservative is accepted as a ‘leach resistant’ water-borne preservative. Comparative leaching studies have been undertaken to compare leaching from Blue Preserve Type DC treated timber with existing leaching of approved alkaline copper quaternary (ACQ) formulations. 5.13 Freshly treated timber is held on a drip pad or protected area to allow the timber to surface dry before it is moved off-site. Disposal 5.14 Empty concentrate containers will be rinsed with clean water, washings disposed of into the treatment system, and the containers recycled or crushed and disposed of locally. 5.15 Delivery by returnable IBCs or by bulk tanker to New Zealand sites means there will be no empty containers to dispose of. Returnable IBCs and tankers are rinsed with clean water, the washings returned to the treatment system and the containers recycled. Damaged containers are washed, crushed and disposed of to an approved landfill. 5.16 The treated timber at the end of its service life, or off-cuts, will be disposed of at an approved landfill licensed to accept hazardous waste. The treated timber will contain copper which will not biodegrade. Other components are biodegradable. 5.17 The applicant states that the burning of preservative treated timber is not recommended, nor use for home heating fires or barbeques. Conclusion 5.18 Risks during transport and use are managed by use of appropriate transport regulations, packaging, labelling, and signage and by using specialist operators. The most significant risks of adverse environmental events arise from potential spills as a consequence of a road accident, transfer to a storage tank, and transfer from a storage tank containing concentrate or dilute preservative solution or transfer from a treatment vessel at the treatment site. 5.19 Mattersmiths Holdings Ltd believe that following normal manufacturing practice, the OSH timber treatment Code of Practice and disposal guidelines and with adherence to the HSNO default controls any potential adverse risks during the product life cycle (manufacture, transport, use and disposal) will be minimised. 5.20 Overall risks posed by the substance and its use are the same as for the reference substance. Accordingly, a detailed risk assessment on Blue Preserve Type DC is not warranted. 5.21 Taking into account the similar use of Blue Preserve Type DC and the reference substance, I consider that the risks associated with the use of Blue Preserve Type DC will be no greater than those of the reference substance. 5.22 I note that there are no other matters (section 6) that would prevent this application for Blue Preserve Type DC from being approved by rapid assessment. Environmental Risk Management Authority Decision: Application HSR06047 Page 6 of 22 5.23 I therefore consider that, given the similarities in composition, hazard properties and the risks associated with the life-cycle, the controls as applied to the reference substance are equally applicable to Blue Preserve Type DC including the following variations: Additional Controls under Section 77A 5.24 The following controls are applied to Blue Preserve Type DC under section 77A: 5.25 “Blue Preserve Type DC shall only be used as an agent in the preservation treatment of timber at industrial sites” 5.26 I consider that this control is appropriate because of the intended use of the substance and note that a similar use restriction has been placed on the reference substance. 5.27 “The controls relating to stationary container systems (as provided in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1(1) of the schedule.” 5.28 I note that, as a means of managing the risks from Blue Preserve Type DC, additional controls relating to stationary container systems are necessary. These provisions are currently provided in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (New Zealand Gazette of 26 March 2004, No. 35, as amended by No. 128, 1 October 2004 and No. 208, 16 December 2005). 5.29 These additional controls are applied to the reference substance and I consider them to be equally applicable to Blue Preserve Type DC. 5.30 The following subclauses shall be added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. Regulation 36 relates to level 3 emergency management requirements. I consider that as a means of managing the risks from Blue Preserve Type DC, the above sub-clauses are necessary. I note that these sub-clauses have been applied to the reference substance by Gazette Notice (Issue No. 72). I consider that these controls are relevant to this substance, and note that no other such controls have been specified under the HSNO Act. In accordance with section 77A(4)(a) of the HSNO Act, I am 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 Blue Preserve Type DC. Environmental Risk Management Authority Decision: Application HSR06047 Page 7 of 22 Variation of Controls under Section 77 5.31 Control code I16 (Regulation 25 of the Hazardous Substance (Identification) Regulations 2001) relates to requirements for identifying on the substance label every ingredient that would, independently of any other ingredient, give Blue Preserve Type DC a hazard classification of 6.8 and 6.9. Noting that this substance does not pose a high risk to human health, I consider that this control may be varied under section 77(4)(a) so that component B1 that would, independently of any other ingredient, cause Blue Preserve Type DC to be classified as a 6.8 substance, does not require identification on the substance label. I consider that this variation should only apply to the substance label and that documentation requirements (Regulation 39 of the Hazardous Substances (Identification) Regulations 2001) apply as though control I16 has not been varied. Components required to be identified on the label and documentation are summarised below: Substance Label Components to be Identified copper complex didecyldimethylammonium compound Documentation (eg SDS) copper complex didecyldimethylammonium compound Component B1 5.32 The following controls have not been listed as the conditions required for the controls to be triggered are not met: Control T8, specifying the requirements for class 6.1 substances that are (lawfully) laid or applied outdoors for terrestrial vertebrate pest control. If it was ever intended to use Blue Preserve Type DC as a vertebrate poison, this would require registration under the Agricultural Compounds and Veterinary Medicines Act 1997 and would trigger a reassessment under the HSNO Act. Control E2, specifying requirements relating to application rates, as this control only applies to substances applied to an area of land, air or water. Control E4, as it relates to class 9.3 substances that are intentionally released into the environment in granular or coated seeds for the purposes of terrestrial vertebrate pest control. Control E5, as it relates to highly ecotoxic substances used for biocidal action in an application from which the substance is likely to enter air or water. 5.33 Control T1 relates to the setting of Tolerable Exposure Limits (TELs). It is considered this control is not applicable for this substance as the requirement to set an Acceptable Daily Exposure (ADE) was not met and also for consistency with the reference substance. I consider that under the conditions of normal use, non-worker exposure would be limited to contact with raw treated timber surfaces, and such exposures would be unlikely to result in an appreciable toxic effect. 5.34 Control T2 relates to controlling exposure in places of work through the setting of WESs. WES values specified in the document described as “Workplace Exposure Standards”, published by the Occupational Safety and Health Service (OSH), Department of Labour, January 2002, are adopted. It is noted that a WES has been set by the Department of Labour for copper dusts and mists. I have adopted this value for Blue Preserve Type DC: Copper Dusts and Mists: Time Weighted Average (TWA) of 1 mg/m3. Environmental Risk Management Authority Decision: Application HSR06047 Page 8 of 22 5.35 Control E1 relates to the setting of Environmental Exposure Limits (EELs). The following water EEL was derived for component B1 in a previous application (approval HSR002695) and is applicable here: Component B1: EEL water = 0.18µg/L 5.36 Controls E7, AH1 and TR1 relate to approved handler and tracking requirements. The Agency notes that this substance is not intended for wide-dispersive use and considers that the requirements for tracking and approved handlers may be deleted under section 77(4)(a). 5.37 Controls T4 and E6, are combined under section 77(5) as they both relate to requirements for equipment used to handle hazardous substances. 5.38 Controls P3, P13, P14 and P15 are combined (section 77(5)) as they all relate to packaging requirements for this substance, with P14 taking effect as the most stringent of the controls. 5.39 Controls D4 and D5 are combined (section 77(5)) as they both relate to disposal requirements for this substance. 5.40 There have also been changes in legislation subsequent to the approval of the reference substance. These regulatory changes now also apply to the reference substance (section 77(2)(a)). 5.41 The list of controls for Blue Preserve Type DC is detailed in Appendix 1. 6 Environmental User Charges 6.1 Section 96 of the HSNO Act provides that the Authority may identify and report to the Minister where it considers that a reduction in the likely occurrence of adverse effects similar to that achieved by the controls attached to any substance could be achieved by any environmental user charge, or a combination of an environmental user charge and controls. 6.2 I consider that the use of controls is the most effective means of managing the risks throughout the life cycle of Blue Preserve Type DC. The imposition of an environmental user charge instead of, or in combination with controls, is therefore not required at this time. 7 Decision 7.1 Having considered the composition and hazardous properties for Blue Preserve Type DC, I am satisfied that this substance meets the criteria for rapid assessment under section 28A(2)(a) of the HSNO Act in that it has a similar composition and similar hazardous properties to an approved substance. 7.2 In considering Blue Preserve Type DC to be similar to an existing substance approved under section 29 of the HSNO Act, in accordance with clause 36(2)(b) of the Methodology, I have considered section 28A(2)(a) of the HSNO Act and also applied the following criteria in the Methodology: Environmental Risk Management Authority Decision: Application HSR06047 Page 9 of 22 clause 9 – equivalent of sections 5, 6 and 8; clause 12 – evaluation of assessment of risks; clause 21 – the decision accords with the requirements of the Act and regulations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; and clause 35 – the costs and benefits of varying the default controls. 7.3 Having regard for the controls that applied to the reference substance, I am satisfied that the controls imposed will be adequate to manage the adverse effects of Blue Preserve Type DC. 7.4 The application is accordingly approved pursuant to section 28A(2)(a) of the HSNO Act with controls as listed in Appendix 1. Rob Forlong Date 10 July 2006 Chief Executive, ERMA New Zealand ERMA New Zealand Approval code: Blue Preserve Type DC Environmental Risk Management Authority Decision: Application HSR06047 HSR002700 Page 10 of 22 Appendix 1: Controls Applying to Blue Preserve Type DC The controls imposed on Blue Preserve Type DC are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New Zealand publication “User Guide to HSNO Control Regulations” provides useful guidance on the controls. Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T2 29, 30 Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of Blue Preserve Type DC. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. The following WES has been set: Copper Dusts and Mists: TWA = 1 mg/m3 T4, E6 7 Requirements for equipment used to handle hazardous substances Any equipment used to handle Blue Preserve Type DC (e.g. impregnation equipment) must retain and/or dispense Blue Preserve Type DC in the manner intended, i.e. 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 Blue Preserve Type DC is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with Blue Preserve Type DC and is not directly exposed to a concentration of Blue Preserve Type DC that is greater than the WES for it. 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 Blue Preserve Type DC, the maximum quantity per package of Blue Preserve Type DC permitted to be carried on passenger service vehicles is 1.0 L. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 Limiting exposure to ecotoxic substances This control relates to the setting of environmental exposure limits (EELs). An EEL establishes the maximum concentration of Blue Preserve Type DC legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition). An EEL can be established by one of three means: applying the default EELs specified; adopting an established EEL; calculating an EEL from an assessment of available ecotoxicological data. The following EEL has been set: Component B1: EELwater = 0.18µg/L 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. Environmental Risk Management Authority Decision: Application HSR06047 Page 11 of 22 Control Code1 Regulation2 Explanation3 Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of Blue Preserve Type DC in terms of: information that must be “immediately available” with Blue Preserve Type DC (priority and secondary identifiers). This information is generally provided by way of the product label; documentation that must be available in the workplace, generally provided by way of SDS; signage at a place where there is a large quantity of Blue Preserve Type DC. I1 6, 7, 32-35, 36 General identification requirements (1)-(7) These controls relate to the duties of suppliers and persons in charge of Blue Preserve Type DC 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 Blue Preserve Type DC 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 Blue Preserve Type DC 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 Blue Preserve Type DC (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 Blue Preserve Type DC 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 Blue Preserve Type DC within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with Blue Preserve Type DC (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds, e.g. on the label All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, e.g. on the label. Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily understandable and in English; any information provided in written or pictorial form must be able to be Environmental Risk Management Authority Decision: Application HSR06047 Page 12 of 22 Control Code1 Regulation2 I2 8 I3 I8 9 14 I9 18 I10 19 Explanation3 easily read or perceived by a person with average eyesight under normal lighting conditions; any information provided in an audible form must be able to be easily heard by a person with average hearing; any information provided must be in a durable format i.e. the information requirements with respect to clarity must be able to be met throughout the lifetime of the (packaged) Blue Preserve Type DC under the normal conditions of storage, handling and use. Priority identifiers for corrosive substances This requirement specifies that Blue Preserve Type DC must be prominently identified as being corrosive. In addition, information must be provided on the need to prevent access to Blue Preserve Type DC by children, unless the substance is being used in a place of work, or part of a place of work, where children will not lawfully be present. This information must be available to any person handling Blue Preserve Type DC 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 Blue Preserve Type DC must be prominently identified as being ecotoxic. This information must be available to any person handling Blue Preserve Type DC within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for certain toxic substances This requirement specifies that Blue Preserve Type DC must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance (unless it is used in a place of work where the general public may not lawfully be present), and the need to restrict access to the substance by children. This information must be available to any person handling Blue Preserve Type DC 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 Blue Preserve Type DC 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 Blue Preserve Type DC. 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 (i.e. Environmental Risk Management Authority Decision: Application HSR06047 Page 13 of 22 Control Code1 Regulation2 I11 20 I16 25 I17 26 Explanation3 corrosive to dermal tissue and ocular tissue); 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; the name and concentration of Components A and B1. Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for Blue Preserve Type DC. 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 (i.e. very ecotoxic in the aquatic environment, harmful to terrestrial vertebrates). Secondary identifiers for toxic substances This control relates to the additional label detail required for Blue Preserve Type DC. 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 (i.e. acutely toxic, suspected human reproductive or developmental toxicant, harmful to human target organs or systems); an indication of the circumstances in which it may harm human beings; an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm; an indication of the steps to be taken to prevent harm to human beings. Use of Generic Names This control provides the option of using a generic name to identify groups of ingredients where such ingredients are required to be listed on the product label as specified by Regulations 19(f) and 25 (e) and (f). A generic name may also be used to identify a specific ingredient required by Regulation 25(f) to be identified, if section 55 or section 57 of the Act applies (withholding information on confidentiality grounds). The generic name must identify the key chemical entities and functional groups in the ingredients that contribute to their hazardous properties. I18 I19 27 29-31 [Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the product label, the name and concentration of Components A and B1]. Use of Concentration Ranges This control provides the option of providing concentration ranges for those ingredients whose concentrations are required to be stated on the product label as specified by Regulations 19(f) and 25(e) and (f). [Regulations 19(f) and 25(e) and (f) specify a requirement to list on the product label, the name and concentration of Components A and B1]. 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 Blue Preserve Type DC is contained in fixed bulk containers or bulk transport Environmental Risk Management Authority Decision: Application HSR06047 Page 14 of 22 Control Code1 Regulation2 Explanation3 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 Blue Preserve Type DC. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if Blue Preserve Type DC 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 Blue Preserve Type DC is in multiple packaging and the outer packaging obscures some or all of the required substance information. In such cases, the outer packaging must: be clearly labelled with all relevant priority identifier information i.e. the hazardous properties of Blue Preserve Type DC 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 bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background); or bear the relevant class or subclass label assigned by the UN Model Regulations. I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for Blue Preserve Type DC that is imported into New Zealand in a closed package or in a freight container and will be transported to its destination without being removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is labelled or marked in compliance with the requirements of the Land Transport Rule 45001. Documentation required in places of work These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets) (Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when Blue Preserve Type DC is held in the workplace in quantities equal to or greater than 1.0 L. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity of Blue Preserve Type DC equal to or greater than 1.0 L, if Blue Preserve Type DC 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 Blue Preserve Type DC 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 Blue Preserve Type DC has access to the documentation required for each hazardous substance concerned. The person Environmental Risk Management Authority Decision: Application HSR06047 Page 15 of 22 Control Code1 Regulation2 Explanation3 in charge must also ensure that the documentation does not contain any information that suggests that Blue Preserve Type DC belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with Blue Preserve Type DC must include the following information: the unequivocal identity of Blue Preserve Type DC (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); a description of the physical state, colour and odour of Blue Preserve Type DC; if the Blue Preserve Type DC’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 Blue Preserve Type DC; the date on which the documentation was prepared; the name, concentration and CAS number of Components A, B1 and B4. Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (e.g. as provided on an SDS). If information required by Regulations 39 to 46 was not included in the information used for the approval of Blue Preserve Type DC 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 Blue Preserve Type DC 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 Blue Preserve Type DC is being transported. I22 40 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 Blue Preserve Type DC is present) if asked to do so by that person. Specific documentation requirements for corrosive substances The documentation provided with Blue Preserve Type DC must include the following information: its general degree and type of corrosive hazard (i.e. corrosive to dermal tissue and ocular tissue); a full description of the circumstances in which it may cause unintentional Environmental Risk Management Authority Decision: Application HSR06047 Page 16 of 22 Control Code1 Regulation2 I23 41 I28 46 I29 51-52 Explanation3 damage to tissue or metallic objects; its pH or pH range. Specific documentation requirements for ecotoxic substances The documentation provided with Blue Preserve Type DC must include the following information: its general degree and type of ecotoxic hazard (i.e. very ecotoxic in the aquatic environment, harmful 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 toxic substances The documentation provided with Blue Preserve Type DC must include the following information: its general degree and type of toxic hazard (i.e. acutely toxic, suspected human reproductive or developmental toxicant, harmful to human target organs or systems); a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; a full description of the steps to be taken to prevent harm to human beings; the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured; a summary of the available acute and chronic (toxicity) data used to define the (toxic) subclass or subclasses in which it is classified; the symptoms or signs of injury or ill health associated with each likely route of exposure; the dose, concentration, or conditions of exposure likely to cause injury or ill health; any TELs or WESs set by the Authority. Duties of persons in charge of places with respect to signage These controls specify the requirements for signage, in terms of content, presentation and positioning at places where Blue Preserve Type DC is held in quantities exceeding 100 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where Blue Preserve Type DC is present at each entrance to rooms or compartments where Blue Preserve Type DC is present; immediately adjacent to the area where Blue Preserve Type DC is located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. toxic); where the signage is immediately adjacent to Blue Preserve Type DC storage areas, describe the precautions needed to safely manage the substance. Environmental Risk Management Authority Decision: Application HSR06047 Page 17 of 22 Control Code1 I30 Regulation2 53 Explanation3 Advertising corrosive and toxic substances Any advertisement for Blue Preserve Type DC must include information that identifies the substance is toxic and 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). In addition, it must specify the general degree and type of hazard (unless it is to be used in a place of work where members of the public may not lawfully be present). Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of Blue Preserve Type DC with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for Blue Preserve Type DC must ensure that, when the package is closed, there is no visible release of Blue Preserve Type DC, 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 reclosed. The packaging in direct contact with Blue Preserve Type DC must not be significantly affected or weakened by contact with Blue Preserve Type DC such that the foregoing requirements cannot be met. Regulation 6 – Packaging markings Packages containing Blue Preserve Type DC 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 Blue Preserve Type DC, 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 Blue Preserve Type DC must not be packed in packaging that has been previously packed with substances with which it is incompatible unless all traces of the previous substance have been removed. Regulation 9A and 9B – Large Packaging Large packaging may be used to contain Blue Preserve Type DC 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 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. Environmental Risk Management Authority Decision: Application HSR06047 Page 18 of 22 P3, P13, P14, P15 9, 19, 20, 21 Packaging requirements for Blue Preserve Type DC Blue Preserve Type DC in quantities over 1.0 L must be packaged according to Schedule 3 (UN PGIII), but must be packaged according to Schedule 3 or Schedule 4 when in quantities equal to or less than 1.0 L. Blue Preserve Type DC that is offered for sale in a package of less than 2.5 L must be in child resistant packaging (i.e. toxic substances liable to be in homes). However, if Blue Preserve Type DC is for use in a place of work to which children do not have access, this requirement is not mandatory. PG3 Schedule 3 This schedule describes the (minimum) packaging requirements that must be complied with for this substance when packaged in quantities of more than 1.0 L. The tests in Schedule 3 correlate to the packaging requirements of UN Packing Group III (UN PGIII). PS4 Schedule 4 This schedule describes the minimum packaging requirements that must be complied with for this substance when packaged in quantities equal to or less than 1.0 L. Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for toxic, ecotoxic and corrosive substances Blue Preserve Type DC must be disposed of by: treating it so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to discharge to the environment; or discharging it to the environment provided that after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone does not exceed any TEL (tolerable exposure limit) or EEL (environmental exposure limit) set by the Authority for that substance; or exporting it from New Zealand as a hazardous waste. D6 10 Disposal requirements for packages of Blue Preserve Type DC 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 Blue Preserve Type DC. In addition, the manner of disposal must take into account the material that the package is manufactured from. D7 11, 12 Disposal information requirements These controls relate to the provision of information concerning disposal (essentially on the label) that must be provided when selling or supplying a quantity of Blue Preserve Type DC that exceeds 0.1 L. D8 13, 14 Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, i.e. that would not comply with the Disposal Regulations. Such information must be accessible to a person handling Blue Preserve Type DC within 10 seconds and must comply with the requirements for comprehensibility, clarity and durability as described in Regulations 34-36 of the Identification Regulations (code I1). Disposal documentation requirements These controls relate to the provision of documentation concerning disposal (essentially in an SDS) that must be provided when selling or supplying a quantity of Blue Preserve Type DC that exceeds 1.0 L. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling Blue Preserve Type DC at a place of work within 10 minutes and must comply with Environmental Risk Management Authority Decision: Application HSR06047 Page 19 of 22 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 Blue Preserve Type DC when present in quantities equal to or greater than 0.1 L. Regulation 6 describes the duties of suppliers, Regulation 7 describes the duties of persons in charge of places, Regulation 9 describes the requirement for the availability of the information (10 seconds) and Regulation 10 gives the requirements relating to the presentation of the information with respect to comprehensibility, clarity and durability. These requirements correspond with those relating to secondary identifiers required by the Identification Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)). EM2 8(a) EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Regulation 11 provides for the option of complying with the information requirements of the transport rules when Blue Preserve Type DC is being transported. Information requirements for corrosive substances The following information must be provided with Blue Preserve Type DC when present in quantities equal to or greater than 0.1 L: a description of the usual symptoms of exposure; a description of the first aid to be given; a 24-hour emergency service telephone number. Information requirements for toxic substances The following information must be provided when Blue Preserve Type DC is present in quantities equal to or greater than 1.0 L: a description of the first aid to be given; a 24-hour emergency service telephone number. Information requirements for ecotoxic substances The following information must be provided with Blue Preserve Type DC when present in quantities equal to or greater than 0.1 L: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent Blue Preserve Type DC from entering or affecting those parts of the environment. Level 2 emergency management documentation requirements These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Safety Data Sheets). This documentation must be provided where Blue Preserve Type DC is sold or supplied, or held in a workplace, in quantities equal to or greater than 1.0 L. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when Blue Preserve Type DC is being transported, and regulation 16 specifies requirements for general contents of the documentation. 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). Environmental Risk Management Authority Decision: Application HSR06047 Page 20 of 22 EM11 EM12 25-34 35-41 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 Blue Preserve Type DC is held (or reasonably likely to be held on occasion) in quantities greater than 100 L. The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be included in the plan is specified in Regulations 29 to 30. Requirements relating to the availability of equipment, materials and people are provided in Regulation 31, requirements regarding the availability of the plan are provided in Regulation 32 and requirements for testing the plan are described in Regulation 33. Level 3 emergency management requirements – secondary containment These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where Blue Preserve Type DC is held in quantities equal to or greater than 100 L. Regulation 36 prescribes requirements for secondary containment systems for pooling substances. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60 L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60 L and 450 L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450 L. Regulation 40 prescribes requirements for places where hazardous substances are held underground. Regulation 41 prescribes requirements for secondary containment systems that contain substances of specific hazard classifications, e.g. there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained). The following subclauses shall be added after subclause (3) of regulation 36: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. EM13 42 Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where Blue Preserve Type DC 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. Environmental Risk Management Authority Decision: Application HSR06047 Page 21 of 22 Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable Containers) applicable Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Additional Controls set under Section 77A Schedule 8, DGTN March The controls relating to stationary container systems, as set out in Schedule 8 2004 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1(1) of that schedule. Blue Preserve Type DC shall only be used as an agent in the preservation treatment of timber at industrial sites. Environmental Risk Management Authority Decision: Application HSR06047 Page 22 of 22