ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION Application code HSR06011 Application type To import or manufacture any hazardous substance under Section 28A(2)(a) of the Hazardous Substances and New Organisms (HSNO) Act 1996 Osmose New Zealand Clendon Town Manukau City Jeremy Christmas Applicant Applicant contact: Purpose Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide: To manufacture oil miscible formulations containing between 32.5 and 50.0 g/L tributyltin oxide as ready-to-use timber preservative solutions. (Rapid Similar) Date received 24 February 2006 Consideration date 05 April 2006 Considered by Rob Forlong (Chief Executive, ERMA New Zealand) 1 Summary of Decision 1.1 The application to import or manufacture Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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: Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 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 manufacture or import Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide for use as a ready-to-use timber preservative. 3.2 The application was formally received on the 24th of February 2006. 3.3 The Ministry of Health and the Department of Labour (Occupational Safety and Health Service - OSH) were advised of the application (clause 2(2)(e)). 3.4 No responses have been received from the Department of Labour or the Ministry of Health. 3.5 Project Team: Brendon Noonan Applications Advisor (Hazardous Substances) Laura Docker Science Advisor (Hazardous Substances) Report review and sign-out by: Dr Peter Dawson 3.6 Principal Scientist (Hazardous Substances) The timeline for assessing this application has been extended because of further informational requirements and the requirement to assess that information. Two section 58 requests for more information have been issued. Two waivers have been issued to allow for delays in the processing of this application. Environmental Risk Management Authority Decision: Application HSR06011 Page 2 of 29 4 Consideration Sequence of the Consideration 4.1 Osmose New Zealand seeks approval under section 28 of the HSNO Act to import or manufacture Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 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: 4.4 To identify the composition and hazardous properties of the proposed substance, Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide, and of the “reference” similar substance provided by the applicant; To determine whether the proposed substance has a similar composition and similar hazardous properties to the reference substance. And then: To determine whether the proposed substance has a similar life-cycle to the reference substance; To consider whether the risks posed by the proposed substance are the same as, less than or greater than those posed by the reference substance; To consider whether there are any other effects which mean that the substance should not be rapidly assessed; and To consider whether the controls that apply under the HSNO Act to the reference substance are applicable to the proposed substance. Information Review 4.5 I have reviewed the information supplied by the applicant 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 the Proposed Substance Relative to that of the Reference Substance 4.6 The applicant has identified a reference substance to which they consider that Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide may be compared. The applicant’s proposed reference substance is “Oil miscible liquid containing 125 g/litre tributyltin oxide” which was transferred to the HSNO Act by the Hazardous Substances (Timber Preservatives, Antisapstains, and Antifouling Paints) Transfer Notice 2004 New Zealand Gazette, 4 June 2004 – Issue No.65, with the approval number HSR000842. Environmental Risk Management Authority Decision: Application HSR06011 Page 3 of 29 4.7 After consideration of the reference substance proposed by the applicant and other potential reference substances identified by the Agency, I consider that there is a valid approved substance against which Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide can be compared. 4.8 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide and the reference substance selected by the Agency contain the same active ingredient, tributyltin oxide, and are both used for preserving timber. 4.9 The compositions of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide and the reference substance are similar in respect to the solvent and excipient components; however, there is a significant reduction in the quantity of the active ingredient. The proposed substance contains between 32.5 and 50.0 g/litre of tributyltin oxide whereas the reference contains 125 g/litre. 4.10 Both the reference and proposed substance take the form of a hydrocarbon solvent based oil miscible liquid. 4.11 After taking the variations in composition into account, I have concluded that the proposed and selected reference substances are of the same nature and kind. Therefore, I am satisfied that Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide has a similar composition and form to the reference substance. Hazardous Properties of the Proposed Substance Relative to the Reference Substance 4.12 The applicant has provided information related to the hazardous properties of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 4.13 Under section 28A(2)(a), the proposed substance must have similar hazardous properties to the reference substance selected by the Agency. The hazardous properties of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide and the reference substance are listed in the following table. Hazardous property Flammability Acute oral toxicity Acute dermal toxicity Acute inhalation toxicity Skin irritation Eye irritation Reproductive / Developmental toxicity Target organ toxicity Aquatic ecotoxicity Soil ecotoxicity Terrestrial vertebrate ecotoxicity Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide Hazard classification 3.1C 6.1D 6.1E 6.1D 6.3B -6.8B 6.9B 9.1A 9.2B 9.3C Environmental Risk Management Authority Decision: Application HSR06011 Reference Substance Hazard classification 3.1C 6.1C 6.1B 6.1B 6.3A 6.4A 6.8B 6.9A 9.1A 9.2B 9.3B Page 4 of 29 4.14 The hazard profile assessed for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide does not change within the composition range specified. 4.15 From comparison of the hazard profile for the proposed substance against that of the reference substance it is apparent that the proposed substance poses a similar array of hazards. However, in many areas hazards from the proposed substance are reduced in comparison to the selected reference substance. For example, the human toxicity is reduced across the board with the exception of Reproductive / Developmental toxicity. The proposed substance’s soil and aquatic ecotoxicity remains on par with that of the reference substance but the ecotoxicity to terrestrial vertebrates is reduced. 4.16 In light of this data, I consider that the hazardous properties of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide and the reference substance are similar. I note that where a hazard varies, Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide poses that hazard to a lesser degree or that it has not been triggered. Evaluation against the Criteria for Similar Composition and Similar Hazardous Properties 4.17 I consider that, based on the application submitted by the applicant, and on information available on the reference substances, the analysis in the preceding paragraphs shows that the criteria for similar composition and similar hazardous properties prescribed under section 28A(2)(a) have been met. Part II (non-scientific) matters 4.18 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 a particular hazardous substance or new organism; New Zealand’s international obligations. 5 Life-cycle, Risks and Controls 5.1 The applicant has indicated that the lifecycle of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is similar to that for the proposed reference substance. The Agency has assessed the lifecycles of the proposed and the selected reference substance and their similarities in composition and hazardous properties and considers that no new or increased risks will arise from the manufacture, distribution and use of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide within New Zealand. Environmental Risk Management Authority Decision: Application HSR06011 Page 5 of 29 5.2 Manufacture of the substance will be carried out in New Zealand within facilities designed for the manufacture of Light Organic Solvent timber Preservatives (LOSPs). The formulation will be supplied by tanker or occasionally in 200 litre mild steel drums, in a ready to use (RTU) format. The RTU Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide will be supplied to users in industrial premises only where it will be vacuum impregnated into dry timber. The application and use of timber treatments are required to follow Best Practice Guidelines produced by the industry and meet the requirements of New Zealand Standard NZS3602:2003 Timber and wood-based products for use in building. 5.3 Due to the similarities in form and use, the disposal of the substance, its packaging or cleansing of tankers is not expected to pose any new or increased risks throughout the proposed substance’s lifecycle. 5.4 The lifecycle of the proposed substance varies slightly from that of the reference substance in that the reference substance does not come in a ready to use format. Instead, the reference substance requires dilution with additional hydrocarbon solvent prior to application. Although this means that there will be a greater quantity of the proposed substance transported around the country, in comparison to the reference alone, the total quantity of hazardous substance being transported will be similar to that of the reference substance when considering the requirement for the transport of the diluent. 5.5 From the assessment of risk over the substance’s lifecycle, I consider that the manufacture and use of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide as a timber treatment will not pose any new or increased risks to human health or to the environment. 5.6 Due to the similarities in lifecycle and form and considering the reduced hazard profile, I consider that the controls imposed on the reference substance are equally applicable to Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide with the exception of the following; PG2, T3 and T6 as they are not triggered by the substance’s hazard classification. Additional Controls under Section 77A 5.7 Under section 77A of the HSNO Act, the Authority may impose as controls any obligations and restrictions as the Authority thinks fit. Under section 77A(4), the Authority must be satisfied that, against any other specified controls that apply to the substance, (a) the proposed control is more effective in terms of its effect on the management, use and risks of the substance; or (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of the substance; or (c) the proposed control is more likely to achieve its purpose. 5.8 The following additional controls have been set for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide: 5.9 “The use of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide shall be limited to that of a timber preservative”. Environmental Risk Management Authority Decision: Application HSR06011 Page 6 of 29 5.10 I consider that this control is appropriate because of the prescribed use of the substance, and that a similar use restriction has been placed on the reference substance. I also consider that this additional control meets the requirements of section 77A(4)(a) in that it will be more effective in terms of the management of the use and risks of the proposed substance. 5.11 “The controls relating to stationary container systems, as set out 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 that schedule.” 5.12 “The controls relating to secondary containment, as set out in Schedule 9 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.” 5.13 “The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, set out in Schedule 10 of the 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 of that schedule.” 5.14 I consider that the addition of the controls from paragraphs 5.11 to 5.13 are appropriate under section 77A(4)(a) for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. This is because no other such controls have been triggered by the hazard profile for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide and they are considered to provide effective management of the risks associated with the substance. Variation of Controls under Section 77 5.15 Under section 77(3), (4) and (5), the default controls determined by the hazardous properties of the substance may be varied. 5.16 The following variations apply to Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide: 5.17 ERMA New Zealand is considering a range of issues to do with TELs and EELs, including their setting, measurement and enforcement following the passage of amendments to the HSNO Act in December 2005. 5.18 Accordingly, no TELs (Control T1) or EELs (Control E1) are being set for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide at this time under Regulations 24 and 35 respectively of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001. The requirement for setting of default EELs described in regulation 32 Environmental Risk Management Authority Decision: Application HSR06011 Page 7 of 29 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 has been deleted. 5.19 Further consultation on these controls will be undertaken if TELs or EELs are to be set for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 5.20 Control T2 relates to the requirement to set Workplace Exposure Standards (WESs). The Department of Labour has established a WES for the solvent, component F, of 525 mg/m3 (TWA) and this is considered to be applicable to the solvent component of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 5.21 Control E5 relates to the requirement to keep records of use of ecotoxic substances when it is applied for biocidal purposes in an application area. When used as timber preservative, I consider that these controls are inappropriate for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide because its application methods do not fit within the definition of the control. Consequently, the requirements of control E5 have been deleted. 5.22 Control E7 and AH1 relate to the requirement for certain ecotoxic substances to be under the control of approved handlers during specific lifecycle stages. This control has been deleted for the reference substance and this deletion is considered to be equally applicable to the proposed substance. Therefore, the requirements of controls E7 and AH1 have been deleted for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 5.23 Control EM12 relates to the requirement for secondary containment systems to be installed at any fixed location where hazardous liquids are held. I consider that this control be modified with the addition of the following after subclause (3) of Regulation 36 of the Hazardous Substances (Emergency Management Controls) 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 loss of containment in the pipework that it(a) is not to be take into account in determining whether a place is required to have a secondary containment system. (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; and (b) includes a process pipeline or a transfer line.” 5.24 Control TR1 relates to the requirement for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide to be tracked throughout its lifecycle. I note that the tracking requirement for the reference substance has not been deleted. However, this was due to the higher acute toxicity of the reference substance. In the case of the proposed substance the tracking control is triggered solely by the substance’s aquatic ecotoxicity classification. Consistent with Authority Policy (November 2003) whereby tracking controls triggered specifically by ecotoxic hazards may be deleted I consider that control Environmental Risk Management Authority Decision: Application HSR06011 Page 8 of 29 TR1 should be deleted for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 5.25 Controls T4 and E6 are combined as they both relate to the same regulation pertaining to requirements for equipment used to handle hazardous substances. 5.26 Controls D2, D4 and D5 have been combined as they all relate to disposal requirements. 5.27 Controls P3, P5, P13 and P15 have been combined as they relate to the packaging requirements for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 5.28 I note that changes in regulations subsequent to the approval of the reference substance will apply to the proposed and reference substance (section 77(2)(a)). 5.29 The list of controls for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide are 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. The imposition of an environmental user charge instead of, or in combination with controls, is therefore not required at this time. 7 Conclusion 7.1 I conclude that the criteria under section 28A(2)(a) for rapid assessment of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide have been met. 7.2 I consider that there are no other factors, such as use patterns, which might lead to an increase in risk or adverse effects from the reference substance. 7.3 I consider that the controls listed in Appendix 1 should apply to Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. Environmental Risk Management Authority Decision: Application HSR06011 Page 9 of 29 8 Decision 8.1 Having considered the composition and hazardous properties for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide, 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. 8.2 In considering Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 Act and also applied the following criteria in the Methodology: 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 HSNO Act and regulations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; and clause 35 – the costs and benefits of varying the default controls. 8.3 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 8.4 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 Chief Executive, ERMA New Zealand ERMA New Zealand Approval Code: Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide: Environmental Risk Management Authority Decision: Application HSR06011 HSR002465 Page 10 of 29 Appendix 1: Controls Applying to Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide The controls imposed on Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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. Default Control Codes and Explanations Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property Controls F1 7 General test certification requirements for all class 1 to 5 substances Where a test certificate is required for a hazardous substance location holding Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide, that test certificate must be issued by an approved test certifier and must typically be renewed yearly. However, the Authority can, on request by the persons required to obtain the test certificate, extend the time period to three years. F2 8 General public transportation restrictions and requirements for Oil T7 10 miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide F3 F5 55 58-59 The maximum quantity per package of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide permitted to be carried on passenger service vehicles is 10 litres. General limits on flammable substances Where Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present at a place for longer than 18 hours, and in a quantity that exceeds; for Closed Containers: 500 litres in containers greater than 5 litres, or 1,500 litres in containers up to and including 5 litres, or for Open Containers 250 litres that substance must be held at a hazardous substance location or transit depot as appropriate. Requirements for hazardous atmosphere zones for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. There is a requirement to establish a hazardous atmosphere zone wherever Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present in quantities greater than; 100 litres (closed) 25 litres (decanting) 5 litres (open occasionally) 1 litre (if in open container for continuous use) 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 HSR06011 Page 11 of 29 Control Code1 Regulation2 Explanation3 The zone must comply with either of the AS/NZS Standards as listed in Regulation 58(a)-(b) or with an ERMA approved code of practice. F6 60-70 Regulation 59 discusses the application of other legislation with respect to electrical systems located within a hazardous atmosphere zone. Specifically, any controls placed on electrical systems or electrical equipment within a hazardous atmosphere zone must be consistent with any controls on such systems/equipment set under other legislation if they are relevant to that specific location. This is to ensure that any potential ignition sources from electrical system or electrical equipment are protected or insulated to an extent that is consistent with the degree of hazard. Requirements to reduce the likelihood of unintended ignition of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. These regulations prescribe controls to reduce the likelihood of unintended ignition of class 2.1.1 flammable gases, class 2.1.2 flammable aerosols and class 3.1 flammable liquids. Controls are prescribed with the aim of covering all foreseeable circumstances in which unintended ignition could take place, and include: placing limits on the proportion of flammable vapour to air to ensure that the proportion of flammable vapour to air will always be sufficiently outside the flammable range, so that ignition cannot take place, and ensuring that there is insufficient energy available for ignition. This energy could be in the form of either temperature or ignition energy (e.g. a spark). Accordingly, the controls provide two approaches to ensure that there is insufficient energy for ignition: (1) keeping the temperature of the substance, or the temperature of any surface in contact with the substance, below 80% of the auto-ignition temperature of the substance, and (2) keeping sources of ignition below the minimum ignition energy, either by removal of the ignition source from any location where flammable substances are handled, or by protecting the “general” mass of flammable material from the ignition source, e.g. by enclosing any ignition sources in an enclosure that will not allow the propagation of the flame to the outside; or using flameproof motors especially designed to prevent ignition energy escaping. F11 76 It should be noted that any person handling any quantity of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide under any of regulations 63(4), 65, 67 and 69 must be an approved handler for that substance, i.e. the trigger quantities that typically activate approved handler requirements do not apply [Regulation 60(2)]. Segregation of incompatible substances In order to reduce the likelihood of unintended ignition of flammable substances, there is a requirement to ensure that Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide does not come into contact with any incompatible substance or material. There is also a requirement that packages of incompatible substances are held separately. Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is Environmental Risk Management Authority Decision: Application HSR06011 Page 12 of 29 Control Code1 F12 Regulation2 77 Explanation3 incompatible with all class 1, 2 3.2, 4 and 5 substances. This regulation does not apply to substances that are located on a vehicle, ship or aircraft if they are segregated in accordance with the Land Transport Rules, the Maritime Rules or the Civil Aviation Rules as relevant. Requirement to establish a hazardous substance location when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present There is a requirement to establish a hazardous substance location where Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present in quantities greater than; for Closed Containers: 500 litres in containers greater than 5 litres, or 1,500 litres in containers up to and including 5 litres, or for Open Containers 250 litres and is held for a period exceeding 18 hours. F14 81 Within such zones, there is a requirement for the person in charge to: notify the responsible enforcement authority of the locality and capacity of the hazardous substance location where relevant, ensure that the substances will be under the control of an approved handler and that the requirements of regulation 56 are met ensure that any location test certification requirements are met ensure that a site plan is available for inspection establish and manage a hazardous atmosphere zone when required (as prescribed by regulation 58) Test certification requirements for facilities where Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present There is a test certification requirement when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present at any hazardous substance location when in quantities above. for Closed Containers: 500 litres in containers greater than 5 litres, or 1,500 litres in containers up to and including 5 litres, or for Open Containers 250 litres That test certificate must be issued by an approved test certifier and must demonstrate compliance with a number of specified controls, including: ensuring that the responsible enforcement authority has been notified of the locality and capacity of the hazardous substance location approved handler requirements security requirements hazardous atmosphere zone requirements, including controls on electrical systems and electrical equipment segregation of incompatible substances signage requirements emergency management requirements, including fire-fighting equipment, emergency response plans and secondary containment ensuring that a site plan is available for inspection Environmental Risk Management Authority Decision: Application HSR06011 Page 13 of 29 Control Code1 F16 Regulation2 83 Explanation3 Controls on transit depots where Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present Transit depots are places designed to hold hazardous substances (in containers that remain unopened) for a period of up to three days, but for periods that are more than 18 hours. Whenever Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is held at a transit depot in quantities exceeding; for Closed Containers: 500 litres in containers greater than 5 litres, or 1,500 litres in containers up to and including 5 litres, or for Open Containers 250 litres there is a requirement for the person in charge to: notify the responsible enforcement authority of the locality and capacity of the hazardous substance location where relevant, ensure that the substances will be under the control of an approved handler ensure that any road vehicle loaded with containers of class 2, 3 or 4 substances is not less than 3 m from any other vehicle or container containing compatible hazardous substances, and not less than 5 m from any other vehicle or container containing incompatible hazardous substances, ensure that containers of class 2, 3 or 4 substances held in the transit depot (but not loaded onto a vehicle) are not less than 5 m from containers of incompatible substances ensure that all class 2, 3 or 4 substances remain in their containers and the containers remain closed ensure the safety of any electrical equipment comply with any signage requirements comply with relevant parts of other Acts and Regulations, e.g. Electricity Act 1992, HSE (Mining Underground Regulations) 1999 or Civil Aviation Rules. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T1 11-27 Limiting exposure to toxic substances This control relates to limiting public exposure to Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested and; it is a substance to which people are likely to be exposed to during their lifetime, and; Environmental Risk Management Authority Decision: Application HSR06011 Page 14 of 29 Control Code1 Regulation2 Explanation3 exposure is likely to result in an appreciable toxic effect. If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns. T2 T4 E6 29, 30 7 No TELs are set for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide at this time. Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 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 are set; Component F – 525 mg/m3 (TWA) Requirements for equipment used to handle hazardous substances As provided by section 77(5), the requirement to use equipment to handle toxic and ecotoxic substances have been combined. Any equipment used to Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide (e.g. pressure treatment equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved. T5 8 Requirements for protective clothing and equipment Protective clothing/equipment must be employed when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with the substance and is not directly exposed to a concentration of the substances that is greater than the WES for that substance. The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing/equipment may be used, and the requirements for maintaining the clothing/equipment. Hazardous Substances (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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition). An EEL can be established by one of three means: applying the default EELs specified adopting an established EEL calculating an EEL from an assessment of available ecotoxicological data. No EELs are set for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide at this time. Environmental Risk Management Authority Decision: Application HSR06011 Page 15 of 29 Control Code1 Regulation2 Explanation3 Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide in terms of: information that must be “immediately available” with the substance (priority and secondary identifiers). This information is generally provided by way of the product label documentation that must be available in the workplace, generally provided by way of SDS signage at a place where there is a large quantity of the substance. I1 6, 7, 32-35, 36 General identification requirements (1)-(7) These controls relate to the duties of suppliers and persons in charge of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide with respect to identification (essentially labelling) (Regulations 6 and 7), accessibility of the required information (Regulations 32 and 33) and presentation of the required information with respect to comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7)) Regulation 6 – Identification duties of suppliers Suppliers of any Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8-17) and secondary identifier information (as required by Regulations 18-30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information available within 10 seconds (Regulation 33). Suppliers must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulation 7 – Identification duties of persons in charge Persons in charge of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds, e.g. on the label All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, e.g. on the label. Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information Environmental Risk Management Authority Decision: Application HSR06011 Page 16 of 29 Control Code1 Regulation2 I3 9 I5 I8 11 14 Explanation3 All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily understandable and in English any information provided in written or pictorial form must be able to be easily read or perceived by a person with average eyesight under normal lighting conditions any information provided in an audible form must be able to be easily heard by a person with average hearing any information provided must be in a durable format i.e. the information requirements with respect to clarity must be able to be met throughout the lifetime of the (packaged) substance under the normal conditions of storage, handling and use. Priority identifiers for ecotoxic substances This requirement specifies that Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must be prominently identified as being ecotoxic. This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for flammable substances This requirement specifies that Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must be prominently identified as being flammable. In addition, the following information must be provided: an indication that the substance is liquid information must be provided on its general degree of hazard (e.g. highly flammable) This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for certain toxic substances This requirement specifies that Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance (unless it is used in a place of work where the general public may not lawfully be present), and the need to restrict access to the substance by children. This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. I9 18 Secondary identifiers for all hazardous substances This control relates to detail required Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 Environmental Risk Management Authority Decision: Application HSR06011 Page 17 of 29 Control Code1 Regulation2 I11 20 I13 Regulation 22 I16 25 I17 26 Explanation3 manufacturer to be contacted, either in person or by telephone, and in the case of a substance which, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class or subclass, a description of each likely change and the date by which it is likely to occur. Secondary identifiers for ecotoxic substances This control relates to the additional label detail required for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. 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 (e.g. very toxic to aquatic life) an indication of its general type of hazard (e.g. ecotoxic in the soil environment) Secondary identifiers for flammable substances This control relates to the additional label detail required for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of flammable hazard (e.g. 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of toxic hazard (eg mild skin irritant) an indication of the circumstances in which it may harm human beings an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm an indication of the steps to be taken to prevent harm to human beings the name and concentration of tributyltin oxide 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). Environmental Risk Management Authority Decision: Application HSR06011 Page 18 of 29 Control Code1 Regulation2 Explanation3 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 tributyltin oxide] 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 tributyltin oxide]. 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance. When Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is contained, there is an additional requirement that information must be provided describing any steps to be taken to prevent an unintentional explosion, ignition combustion, acceleration of fire or thermal decomposition. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if the substance is labelled or marked in compliance with the requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. Regulation 30 – Substances in multiple packaging This Regulation relates to situations when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 the substance must be identified, or be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant, or in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background), or bear the relevant class or subclass label assigned by the UN Model Regulations. Environmental Risk Management Authority Decision: Application HSR06011 Page 19 of 29 Control Code1 Regulation2 I20 36(8) I21 37-39, 47-50 Explanation3 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide that is imported into New Zealand in a closed package or in a freight container and will be transported to its destination without being removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is labelled or marked in compliance with the requirements of the Land Transport Rule 45001. Durability of information for class 6.1 substances Any packaging in direct contact with a class Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must be permanently identified as having contained a toxic substance, unless the substance as packaged is restricted to a place of work. Documentation required in places of work These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets) (Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is held in the workplace in quantities equal to or greater than 1.0 litre. 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide equal to or greater than 1.0 litre if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where hazardous substances are present in quantities equal to or greater than those specified in Regulation 38 (and with reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation required for each hazardous substance concerned. The person in charge must also ensure that the documentation does not contain any information that suggests that the substance belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must include the following information: the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)) a description of the physical state, colour and odour of the substance if the substance’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of Environmental Risk Management Authority Decision: Application HSR06011 Page 20 of 29 Control Code1 Regulation2 Explanation3 the temperatures at which the changes in physical state may occur and the nature of those changes. in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur contact details for the New Zealand supplier/manufacturer/importer all emergency management and disposal information required for the substance the date on which the documentation was prepared the name, concentration and CAS number of tributyltin oxide. 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 the substance by the Authority, it is sufficient compliance with those Regulations if reference is made to that information requirement along with a comment indicating that such information is not applicable to that substance. Regulation 48 – Location and presentation requirements for documentation All required documentation must be available to a person handling the substance in a place of work within 10 minutes. The documentation must be readily understandable by any fully-trained worker required to have access to it and must be easily read, under normal lighting conditions, at a distance of not less than 0.3m. Regulation 49 – Documentation requirements for vehicles This Regulation provides for the option of complying with documentation requirements as specified in the various Land, Sea and Air transport rules when the substance is being transported. I23 41 Regulation 50 – Documentation to be supplied on request Notwithstanding Regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present) if asked to do so by that person. Specific documentation requirements for ecotoxic substances The documentation provided with Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must include the following information: its general degree and type of ecotoxic hazard (e.g. 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 Environmental Risk Management Authority Decision: Application HSR06011 Page 21 of 29 Control Code1 Regulation2 I25 43 I28 46 I29 51-52 Explanation3 any EELs set by the Authority. Specific documentation requirements for flammable substances The documentation provided with Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 its lower and upper explosive limits, expressed as volume percentages in air or its flash point (and flash point methodology) and auto-ignition temperature Specific documentation requirements for toxic substances The documentation provided with Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured a summary of the available acute and chronic (toxicity) data used to define the (toxic) subclass or subclasses in which it is classified the symptoms or signs of injury or ill health associated with each likely route of exposure the dose, concentration, or conditions of exposure likely to cause injury or ill health any TELs or WESs set by the Authority. Duties of persons in charge of places with respect to signage These controls specify the requirements for signage, in terms of content, presentation and positioning at places where hazardous substances are held in quantities exceeding the amounts specified in Schedule 3 of the Identification Regulations. Where a substance triggers more than one hazard classification, the most stringent quantity generally applies. These requirements are triggered when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is held in quantities exceeding 100 litres. 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 Environmental Risk Management Authority Decision: Application HSR06011 Page 22 of 29 Control Code1 Regulation2 I30 53 Explanation3 describe the general type of hazard of each substance (e.g. flammable) where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). Advertising corrosive and toxic substances Any advertisement for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must include information that identifies the substance is toxic and indicates the need to restrict access by children. In addition, it must specify the general degree and type of hazard (unless it is used in a place of work where members of the public may not lawfully be present). Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8, General packaging requirements 9A, 9B 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must ensure that, when the package is closed, there is no visible release of the substance, and that it maintains its ability to retain its contents in temperatures from –10oC to +50oC. The packaging must also maintain its ability to retain its remaining contents if part of the contents is removed from the package and the packaging is then re-closed. The packaging in direct contact with the substance must not be significantly affected or weakened by contact with the substance such that the foregoing requirements cannot be met. Regulation 6 – Packaging markings Packages containing Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide, 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide 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 Oil miscible liquid containing 32.5 to Environmental Risk Management Authority Decision: Application HSR06011 Page 23 of 29 Control Code1 Regulation2 P3 P5 P13 P15 9 11 19 21 PG3 Schedule 3 PS4 Schedule 4 Explanation3 50.0 g/litre tributyltin oxide 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. Packaging requirements for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide The packaging requirements for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide are as follows: Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide in quantities over 5 litres must be packaged according to Schedule 3 (UN PGIII), but must be packaged according to either Schedule 3 or Schedule 4 when in quantities below 5 litres. Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide that is offered for sale in a package of less than 2.5 litres must be in child resistant packaging (i.e. toxic substances liable to be in homes). However, if the substance is for use in a place of work to which children do not have access, this requirement is not mandatory. This schedule describes the (minimum) packaging requirements that must be complied with for this substance when packaged in quantities of more than 5 litres. The tests in Schedule 3 correlate to the packaging requirements of UN Packing Group III (UN PGIII). This schedule describes the minimum packaging requirements that must be complied with for this substance when packaged in quantities equal to or less than 5 litres. Hazardous Substances (Disposal) Regulations 2001 D2 6 Disposal requirements for Oil miscible liquid containing 32.5 to 50.0 g/litre D4 8 tributyltin oxide D5 9 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide must be disposed of by: treating the substance so that it is no longer a hazardous substance. exporting the substance from New Zealand as a hazardous waste treatment can include controlled burning providing the performance requirements as set out in regulation 6 (3)(b) of the Disposal Regulations for protecting people and the environment are met, and the burning operation does not exceed any TELs or EELs treatment includes discharge into the environment as waste, or depositing in a landfill, provided the discharge location is managed so that the substance will not at any time come into contact with any substances with explosive or oxidising properties, and Environmental Risk Management Authority Decision: Application HSR06011 Page 24 of 29 Control Code1 Regulation2 Explanation3 there is no ignition source in the vicinity of the disposal site, and in the event of an accidental fire, harm to people or the environment does not occur – the performance requirements for this are set out in regulation 6 (3)(b) of the Disposal Regulations, and D6 10 D7 11, 12 D8 13, 14 after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone does not exceed any TELs or EELs set by the Authority for that substance However, this does not include dilution of the substance with any other substance prior to discharge to the environment Disposal requirements for packages This control gives the disposal requirements for packages that contained Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide and are no longer to be used for that purpose. Such packages must be either decontaminated/treated or rendered incapable of containing any substance (hazardous or otherwise) and then disposed of in a manner that is consistent with the disposal requirements for the substance. In addition, the manner of disposal must take into account the material that the package is manufactured from. Disposal information requirements These controls relate to the provision of information concerning disposal (essentially on the label) that must be provided when selling or supplying a quantity of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide that exceeds 0.1 litre. Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, i.e. that would not comply with the Disposal Regulations. Such information must be accessible to a person handling the substance within 10 seconds and must comply with the requirements for comprehensibility, clarity and durability as described in Regulations 34-36 of the Identification Regulations (code I1). Disposal documentation requirements These controls relate to the provision of documentation concerning disposal (essentially in an SDS) that must be provided when selling or supplying a quantity of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide that exceeds 1.0 litre. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in Regulations 48(2), (3) and (4) of the Identification Regulations (code I21). Hazardous Substances (Emergency Management) Regulations 2001 EM1 6, 7, 9-11 Level 1 emergency management information: General requirements These controls relate to the provision of emergency management information (essentially on the label) that must be provided with Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide when present in quantities equal to or greater than 0.1 litre. Environmental Risk Management Authority Decision: Application HSR06011 Page 25 of 29 Control Code1 Regulation2 EM6 8(e) EM7 8(f) EM8 12-16, 18-20 EM9 17 EM10 21-24 Explanation3 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)). Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. Information requirements for toxic substances The following information must be provided when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is present in quantities equal to or greater than 0.1 litre: 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 Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide when present in quantities equal to or greater than 0.1 litre. a description of the parts of the environment likely to be immediately affected by it: a description of its typical effects on those parts of the environment a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment. Level 2 emergency management information requirements These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Safety Data Sheets). This documentation must be provided where Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is sold or supplied, or held in a workplace, in quantities equal to or greater than 1.0 litre. 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. Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Specific documentation requirements for flammable and oxidising substances and organic peroxides There is an additional requirement for Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide, that a description be provided of the steps to be taken to control any fire involving the substance, including the types of extinguishant to be used. Fire extinguishers Every place (including vehicles) where Oil miscible liquid containing 32.5 to Environmental Risk Management Authority Decision: Application HSR06011 Page 26 of 29 Control Code1 EM11 Regulation2 25-34 Explanation3 50.0 g/litre tributyltin oxide is held in a place of work in quantities exceeding 500 litres must have the 2 fire extinguishers. The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching hazardous substances, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of hazardous substances. Each fire extinguisher must be located within 30m of the substance, or, in a transportation situation, in or on the vehicle (Regulation 22). The performance measure for an extinguisher is that it must be capable of extinguishing a fully ignited pool of flammable liquid (50mm deep and at least 6m2 in area), before the extinguisher is exhausted, and when used by one person (Regulation 23). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where hazardous substances are held (or reasonably likely to be held on occasion) in quantities greater than those specified in Schedule 4 of the Emergency Management Regulations. Where a substance triggers more than one hazard classification, the most stringent quantity generally applies. These requirements are triggered when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is held (or reasonably likely to be held on occasion) in quantities exceeding 100 litres. 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. EM12 35-41 Level 3 emergency management requirements – secondary containment These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where liquid (or liquefiable) hazardous substances are held in quantities equal to or greater than those specified in Schedule 4 of the Emergency Management Regulations. Where a substance triggers more than one hazard classification, the most stringent quantity generally applies. These requirements are triggered when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is held in quantities exceeding 100 litres. Regulation 36 prescribes requirements for secondary containment systems for pooling substances. The following subclauses are added after subclause (3) of Regulation 36 of the Hazardous Substances (Emergency Management Controls) regulations 2001; (4) For the purposes of this regulation, and regulations 37 to 40, Environmental Risk Management Authority Decision: Application HSR06011 Page 27 of 29 Control Code1 EM13 Regulation2 42 Explanation3 where this substance is contained in pipework that is installed and operated so as to manage loss of containment in the pipework that it(a) is not to be take into account in determining whether a place is required to have a secondary containment system. (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; and (b) includes a process pipeline or a transfer line. 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). Level 3 emergency management requirements – signage This control 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 of the Emergency Management Regulations. Where a substance triggers more than one hazard classification, the most stringent quantity generally applies. These requirements are triggered when Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide is held in quantities exceeding 100 litres. The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the Identification Regulations. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 The Hazardous Substances (Tank Wagons and Transportable Containers) to 43 where Regulations 2004 prescribe a number of controls relating to tank wagons and applicable transportable containers and must be complied with as relevant. Section 77A – Additional controls The use of Oil miscible liquid containing 32.5 to 50.0 g/litre tributyltin oxide shall be limited to that of a timber preservative The controls relating to stationary container systems, as set out in Schedule 8 of Schedule 8, DGTN March the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26 March 2004, as 2004 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 Environmental Risk Management Authority Decision: Application HSR06011 Page 28 of 29 Schedule 9, DGTN March 2004 Schedule 10, DGTN March 2004 schedule. The controls relating to secondary containment, as set out in Schedule 9 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. The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, set out in Schedule 10 of the 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 of that schedule. Environmental Risk Management Authority Decision: Application HSR06011 Page 29 of 29