ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 19 December 2006 Application Code HSR06088 Application Type To import or manufacture any hazardous substance under the Hazardous Substances and New Organisms Act 1996 (the Act) Applicant Ceva Animal Health Limited 3/200 Habour View Road Whangamata Date Application Received 24 August 2006 Consideration Date 20 December 2006 Considered by A Committee of the Authority Purpose of the Application To import for release four pheromone products for use in the environment of companion animals (Category A). 1 Summary of decision 1.1 The application to import or manufacture Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser is approved with controls in accordance with the relevant provisions of the Act, the HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology). 1.2 The substances have been given the following unique identifiers for the ERMA New Zealand Hazardous Substances Register: Feliway Spray Feliway Diffuser DAP Spray DAP Diffuser 2 Legislative criteria for application 2.1 The application was lodged pursuant to section 28. The decision was determined in accordance with section 29, taking into account additional matters to be considered in that section and matters specified under Part II of the Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the Act. 2.2 Consideration of the application followed the relevant provisions of the Methodology. Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology. ERMA New Zealand Decision: Application HSR06088 Page 1 of 70 3 Application Process 3.1 The application was formally received on 24 August 2006. 3.2 In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public notification was made on 13 September 2006. 3.3 Submissions closed on 26 October 2006. 3.4 Various government departments (including the Ministry of Health, the Department of Labour Work Place Group and the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the Food Safety Authority), Crown entities and interested parties, which in the opinion of the Authority would be likely to have an interest in the application, were notified of the receipt of the application (sections 53(4) and 58(1)(c), and clauses 2(2)(e) and 5) and provided with an opportunity to comment or make a submission on the application. No comments or submissions were received. 3.5 The Agency was commissioned to prepare an Evaluation and Review Report (the E&R Report) to aid the Committee in its decision making process. The E&R Report consists of the Agency’s review of the application and available data regarding the substances and their constituent components. The E&R Report also contains an assessment of the potential risks the substances pose to the environment, human health, Maori, community and to the economy and proposes a suite of controls suitable to manage those risks. 3.6 The Ministry of Health, the Department of Labour, the ACVM Group of the Food Safety Authority and the applicant were given the opportunity to comment on the E&R Report and the controls proposed therein. No responses were received. 3.7 A public hearing was not required to be held. 3.8 A waiver was issued under section 59 to extend the timeline for preparation of the E&R Report for the Committee’s consideration. 3.9 The following members of the Authority considered the application (section 19(2)(b)): Mr Tony Haggerty (Chair), George Clark and Max Suckling. 3.10 The information available to the Committee comprised: the application, including confidential appendices; and the E&R Report. 4 Consideration Purpose of the application 4.1 The purpose of the application is to gain approval to import or manufacture for release the products Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser, formulations containing cat and dog pheromone analogues. These products are intended for use by veterinarians and pet owners to prevent urine marking/house soiling and to settle cats and dogs into unfamiliar or stressful environments. ERMA New Zealand Decision: Application HSR06088 Page 2 of 70 Sequence of the consideration 4.2 In accordance with clause 24, the approach adopted by the Committee was to: establish the hazard classifications for the substances and derive the default controls. identify potentially non-negligible risks, costs, and benefits. assess potentially non-negligible risks, costs, and benefits in the context of the default controls and possible variations to those controls. Risks were assessed in accordance with clause 12, and costs and benefits in accordance with clause 13. consider and determine variations to the default controls arising from the circumstances provided for in sections 77A and 77 (3), (4) and (5) and then consolidate controls. evaluate overall risks, costs, and benefits to reach a decision. The combined impact of risks, costs and benefits was evaluated in accordance with clause 34, and the cost-effectiveness of the application of controls was considered in accordance with clause 35. Hazard classification 4.3 The Committee agreed with the hazard classification determined by the Agency and classifies the substance as follows: Table 4.1: Summary of HSNO classification of Feliway Spray Hazardous Property Flammable liquid Skin irritancy Eye irritancy Aquatic ecotoxicity Applicant’s Assessment 3.1B 6.3B 6.4A 9.1D Agency’s Assessment 3.1B 6.3B 6.4A 9.1D Table 4.2: Summary of HSNO classification of Feliway Diffuser Hazardous Property Acute toxicity – aspiration hazard Skin irritancy Aquatic ecotoxicity Applicant’s Assessment 6.3B 9.1B Agency’s Assessment 6.1E 6.3B 9.1A Table 4.3: Summary of HSNO classification of DAP Spray Hazardous Property Flammable liquid Acute oral toxicity & aspiration hazard Skin irritancy Eye irritancy Aquatic ecotoxicity ERMA New Zealand Decision: Application HSR06088 Applicant’s Assessment 3.1B 6.3B 6.4A - Agency’s Assessment 3.1B 6.1E 6.3B 6.4A 9.1A Page 3 of 70 Table 4.4: Summary of HSNO classification of DAP Diffuser Hazardous Property Acute toxicity – aspiration hazard Skin irritancy Aquatic ecotoxicity Applicant’s Assessment 6.3B 9.1B Agency’s Assessment 6.1E 6.3B 9.1A Default controls 4.4 The Committee considered that, in the E&R Report, the Agency correctly assigned default controls as set out in the HSNO Regulations. The default controls were used as the reference for subsequent consideration of the application; they are identified in the E&R Report (Tables 8.1 – 8.4) and are not reproduced here. Identification and assessment of the risks, costs and benefits of the substances 4.5 The Committee identified potentially non-negligible risks, costs and benefits with reference to clauses 9 and 11, which incorporate relevant material from sections 2, 5, 6, and 8. Risks 4.6 The risks posed to the biological and physical environment by each of the pheromone products relate to their toxicity in the aquatic environment. The Feliway Diffuser, DAP Spray and DAP Diffuser products are each classified as being very ecotoxic in the aquatic environment (9.1A) while Feliway Spray is classified as being slightly harmful to the aquatic environment (9.1D). Given that each of these products is intended for use in relatively small quantities (with the Spray products being sold in 60 mL glass bottles and the Diffuser products being sold in 48 mL plastic vials) it was considered that the risks to the environment during use are negligible. The Committee considers that during other stages of the products’ lifecycles, the risks to the environment are negligible to low with the controls in place. 4.7 The risks posed by each of the four pheromone products to human health and safety relate to their potential to cause irritation, with each of the four products classified as being irritating to the skin (6.3B) and both the Feliway Spray and DAP Spray products additionally classified as being irritating to the eye (6.4A). While the likelihood of exposure and resulting adverse effects in relation to the irritancy hazards was considered to be slightly greater during use than during any other stage of the lifecycle for each of the four products, given the magnitude of the adverse effects, the overall level of risk is considered to be negligible. 4.8 The Committee notes that the Feliway Diffuser, DAP Spray and DAP Diffuser products pose an aspiration hazard ingested via the oral route (6.1E). In addition to its classification as an aspiration hazard, DAP Spray is considered to be acutely toxic via the oral route. Bearing in mind that a very large dose of DAP spray would need to be ingested in order for a lethal effect to occur, the Committee considers that the risks associated with the acute toxicity hazards for each of these three products are negligible to very low. ERMA New Zealand Decision: Application HSR06088 Page 4 of 70 4.9 In addition to their ecotoxic and toxic hazard classifications, Feliway Spray and DAP Spray were both classified as being flammable (3.1B - high hazard). The risks associated with the flammability of these two products were considered throughout the lifecycle, in terms of both the environmental risk and the risk to human health and safety. Given the controls in place, and the limited quantities being handled during the use stage of the lifecycle, the Committee considers that these risks are negligible to low. 4.10 The Committee does not expect there to be any adverse impacts on the social or economic environment with the controlled use of either Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser. The Committee is unaware of any likely impact that these substances could have on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. The Committee has no evidence to suggest that the controlled use of any of the four pheromone products considered in this application will breach the principles of the Treaty of Waitangi. Costs 4.11 A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. These have been assessed in an integrated fashion together with the risks in the assessment above. 4.12 The Methodology and the Act both call for consideration of monetary and nonmonetary costs (clause 13 and section 9). The Committee is satisfied that there are no significant costs that will result from the release of these substances. Benefits 4.13 A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular positive effect expressed in monetary or non-monetary terms”. Benefits that may arise from any of the matters set out in clauses 9 and 11 were considered in terms of clause 13. 4.14 There are potentially significant benefits associated with the manufacture of these substances arising from increased choice for the end user and increased profits for and employment opportunities within Ceva Animal Health New Zealand Limited. The applicant has identified that the product will benefit animal welfare as it is designed to evoke a sense of calm and well-being in cats and dogs in times of stress. 4.15 The Committee is unable to place an expected value on the benefits (clause 13(b)) but is satisfied that the ability of the substances to enter the market could give rise to the associated benefits. Additional controls under section 77A 4.16 Under section 77A, the Authority may impose as controls any obligations and restrictions that it thinks fit. Before imposing a control under this section, the Authority must be satisfied that, against any other specified controls that apply to the substance: (a) the proposed control is more effective in terms of its effect on the management, use and risks of the substance; or ERMA New Zealand Decision: Application HSR06088 Page 5 of 70 (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of the substance; or (c) the proposed control is more likely to achieve its purpose. 4.17 The following additional controls have been applied to Feliway Spray under section 77A. 4.17.1 4.18 The following additional controls have been applied to Feliway Diffuser under section 77A. 4.18.1 4.19 “The controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances, as set out in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are proposed for this substance, notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10.” The following additional controls have been applied to DAP Diffuser under section 77A. 4.20.1 4.21 "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 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are proposed for this substance, notwithstanding clause 1(1) of that schedule.” The following additional controls have been applied to DAP Spray under section 77A. 4.19.1 4.20 “The controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances, as set out in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are proposed for this substance, notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10.” "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 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are proposed for this substance, notwithstanding clause 1(1) of that schedule.” The Committee considers that these controls are relevant to these substances, and notes that no other such controls have been specified under the Act. In accordance with section 77A(4)(a), the Committee is satisfied that imposing these additional controls is more effective than any other specified controls in terms of their effect on the management, use and risks of Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser. ERMA New Zealand Decision: Application HSR06088 Page 6 of 70 Variation of Controls under Section 77 4.22 Under section 77(3), (4) and (5), the default controls determined by the hazardous properties of the substance may be varied. 4.23 The applicant was given an opportunity to comment on the proposed controls as set out in the E&R Report (clause 35(b). The applicant had no comments to make regarding the controls. 4.24 The Committee decided that the following variations shall apply to the Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser: 4.24.1 Control T1 relates to the requirement to limit public exposure to toxic substances by the setting of Tolerable Exposure Limits (TELs), which are derived from Acceptable Daily Exposure (ADE) values. As the requirements of Regulation 11 are not met, ADEs are not required to be set for any components of these substances. Consequently, the Committee has not set any TEL values for Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser. 4.24.2 Control T2 relates to the requirement to limit worker exposure to toxic substances by the setting of Workplace Exposure Standards (WESs). The Committee considers that the following WES values for components of Feliway Spray and DAP Spray should be adopted: Substance Feliway Spray Feliway Diffuser DAP Diffuser DAP Spray 4.24.3 Components Component DFeliway Spray Component HDAP Spray The Committee notes that Department of Labour WES values have been set for components of Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser but considers that they should not be applied to these substances due to the low concentration of the components in the substances: Substance Feliway Spray Feliway Diffuser DAP Diffuser DAP Spray Components Component AFeliway DIffuser Component BDAP Diffuser Component BDAP Spray 4.24.4 Controls T4 and E6 both relate to requirements for equipment used to handle hazardous substances, and thus are combined under section 77(5) for Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser. 4.24.5 Control E1 relates to the requirements to limit exposure to non-target organisms in the environment by the setting of Environmental Exposure Limits (EELs). The Committee has not set any EELs for any components of Feliway Spray, Feliway Diffuser, DAP Spray, or DAP Diffuser given ERMA New Zealand Decision: Application HSR06088 Page 7 of 70 the use pattern of the substances, and has deleted the default values under section 77(4)(a). 4.24.6 Control E7 relates to requirements for ecotoxic substances to be under the control of an approved handler. This control is triggered for Feliway Diffuser, DAP Spray and DAP Diffuser. Given that the products are intended for use by veterinarians and pet owners, the Committee considers that the requirements specified by the E7 control would be unduly onerous and therefore this control is deleted for Feliway Diffuser, DAP Spray and DAP Diffuser under section 77(4)(b), so that the benefits of the substances can be retained without significantly increasing the risks. Similarly, the Committee has deleted the AH1 control for Feliway Diffuser and DAP Diffuser. The Committee notes that the AH1 control is retained for Feliway Spray and DAP Spray at certain points of the lifecycle, due to the flammability of these two products (refer to F4 control). 4.24.7 Controls P3, P5, P13 and P15 each relate to requirements for packaging hazardous substances, and thus are combined under section 77(5) for DAP Spray. 4.24.8 Controls P3, P5 and P13 are combined under section 77(5) for Feliway Spray. 4.24.9 Controls P3, P13 and P15 are combined under section 77(5) for Feliway Diffuser and DAP Diffuser. 4.24.10 Controls D2, D4 and D5 all relate to disposal requirements, and are combined under section 77(5) for Feliway Spray and DAP Spray. 4.24.11 Controls D4 and D5 are combined under section 77(5) for Feliway Diffuser and DAP Diffuser. 4.24.12 Control TR1 relates to the requirements for a substance to be tracked. Given that the products are intended for use by veterinarians and pet owners, the Committee considers that tracking requirements would be unduly onerous and therefore this have deleted this control under section 77(4)(b) so that the benefits of the substances can be retained without significantly increasing the risks. 4.24.13 Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser are intended for use by domestic pet owners. Given that the four pheromone products will be packaged individually in containers holding less than 100 mL, the Committee has deleted the requirements for priority and secondary identifiers for ecotoxic substances (control codes I3 and I11) under section 77(4)(a) for Feliway Diffuser, DAP Spray and DAP Diffuser. The Committee notes that of the two controls codes, only I11 was triggered for Feliway Spray. The Committee has deleted this control under section 77(4)(a). ERMA New Zealand Decision: Application HSR06088 Page 8 of 70 Establishment of the approach to risk in the light of risk characteristics 4.25 Clause 33 requires the Authority, when considering applications, to have regard for the extent to which a specified set of risk characteristics exist. The intention of this provision is to provide a route for determining how cautious or risk averse the Authority should be in weighing up risks and costs against benefits. Overall evaluation of risks, costs and benefits 4.26 Having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and section 29, risks, costs and benefits were evaluated taking account of all proposed controls including default controls plus proposed variations to the controls. 4.27 Clause 34 sets out the approaches available to the Authority in evaluating the combined impact of risks, costs and benefits (i.e. weighing up risks, costs and benefits). 4.28 The Committee is satisfied that the risks to the environment throughout the lifecycles of each of the four pheromone products are negligible to low with the controls in place. The Committee is also satisfied that the overall risks to human health are negligible to very low throughout the substances’ lifecycles provided that all relevant controls and mitigation measures are followed. 4.29 The Committee does not expect there to be any adverse impacts on the social or economic environment, or on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga with the controlled use of Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser. 4.30 On the basis of the risk assessment, taking into account the approved handler requirements and additional controls set under section 77A, the Committee considers that, overall the risks and costs associated with Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser will be outweighed by the benefits offered. Recommendations 4.31 The Committee recommends that, should inappropriate or accidental misuse, transport or disposal of Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser result in the contamination of waterways, the appropriate authorities, including the relevant iwi authorities in the region, should be notified. This action should include advising them of the contamination and the measures taken in response. Environmental User Charges 4.32 The Committee considers that the application of controls to Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser will provide an effective means of managing the risks associated with this substance. At this time no consideration has been given to whether or not environmental charges should be applied to this substance as an alternative or additional means of achieving effective risk management. ERMA New Zealand Decision: Application HSR06088 Page 9 of 70 5 Decision 5.1 Pursuant to section 29, the Committee has considered this application to import a hazardous substance made under section 28. 5.2 The Committee is satisfied that the default controls, as varied under paragraph 4.26, and the additional controls, set under Paragraphs 4.19 to 4.23, will be adequate to manage the adverse effects of the hazardous substances. 5.3 Having considered all the possible effects of the hazardous substance in accordance with section 29, pursuant to clause 27, based on consideration and analysis of the information provided, and taking into account the application of controls, the view of the Committee is that Feliway Spray, Feliway Diffuser, DAP Spray or DAP Diffuser pose insignificant to very low risks to human health and insignificant to low risks to the environment with the controls in place. 5.4 Consequently, the Committee considers that the benefits associated with the substances outweigh the potential risks and costs. 5.5 In accordance with clause 36(2)(b), the Committee records that, in reaching this conclusion, it has applied the balancing tests in section 29 and clause 27. 5.6 It has also applied the following criteria in the Methodology: clause 9 – equivalent of sections 5, 6 and 8; clause 11 – characteristics of substance; clause 12 – evaluation of assessment of risks; clause 13 – evaluation of assessment of costs and benefits; clause 14 – costs and benefits accruing to New Zealand clause 21 – the decision accords with the requirements and regulations; clause 22 – the evaluation of risks, costs and benefits – relevant considerations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; clause 27 – risks and costs are outweighed by benefits; clause 33 – risk characteristics; clause 34 – the aggregation and comparison of risks, costs and benefits; and clause 35 – the costs and benefits of varying the default controls. 5.7 The application for importation and manufacture of the hazardous substances, Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser are thus approved, with controls listed in Appendix 1. 5.8 Tony Haggerty Date: 19 December 2006 Chair ERMA New Zealand Approval Code: HSR007686 HSR007687 HSR007688 HSR007689 ERMA New Zealand Decision: Application HSR06088 DAP Diffuser Dap Spray Feliway Diffuser Feliway Spray Page 10 of 70 Appendix 1: List of Controls that apply to Feliway Spray, Feliway Diffuser, DAP Spray and DAP Diffuser Note: The control explanations as listed below have been provided as guidance only and do not have legal standing. Please refer to the regulations for the requirements prescribed for each control and the modifications listed set out in section 4 of this document. Table A1.1: Controls for Feliway Spray – codes and explanations Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 -Toxic Property Controls F1 7 General test certification requirements for all class 1 to 5 substances Where a test certificate is required for a hazardous substance location holding flammable substances, that test certificate must be issued by an approved test certifier and must typically be renewed yearly. However, the Authority can, on request by the persons required to obtain the test certificate, extend the time period to three years. F2 8 General public transportation restrictions and requirements for all class 1 to 5 substances The maximum quantity per package of Feliway Spray permitted to be carried on passenger service vehicles is 1 L. F3 55 General limits on flammable substances Feliway Spray must be held at a hazardous substance location or transit depot as appropriate, when present at a place for longer than 18 hours and in a quantity greater than: Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L F4 56 Quantity beyond which controls apply when use occurring in open containers 50 L 50 L Approved handler requirements Feliway Spray must generally be under the personal control of an approved handler or secured to a specified standard, when held in quantities greater than: 250 L when in containers greater than 5 L; or 500 L when in containers up to and including 5 L. However, Feliway Spray may be handled by a person who is not an approved handler if: the approved handler has provided guidance to the person in respect of handling; and 1 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. 3 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. ERMA New Zealand Decision: Application HSR06088 Page 11 of 70 Control Code1 F5 Regulation2 58-59 Explanation3 the approved handler is available at all times to provide assistance if necessary. It should be noted that any person handling any quantity of Feliway Spray 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)]. Requirements for hazardous atmosphere zones for class 2.1.1, class 2.1.2 and class 3.1 substances. A hazardous atmosphere zone must be established for Feliway Spray when present in quantities greater than: 100 L (closed); 25 L (decanting); 5 L (open occasionally) 1 L (if in open container for continuous use). The zone must comply with either of the AS/NZS Standards as listed in Regulation 58(a)-(b) or with an ERMA approved code of practice. F6 60-70 Regulation 59 discusses the application of other legislation with respect to electrical systems located within a hazardous atmosphere zone. Specifically, any controls placed on electrical systems or electrical equipment within a hazardous atmosphere zone must be consistent with any controls on such systems/equipment set under other legislation if they are relevant to that specific location. This is to ensure that any potential ignition sources from electrical system or electrical equipment are protected or insulated to an extent that is consistent with the degree of hazard. Requirements to reduce the likelihood of unintended ignition of class 2.1.1, class 2.1.2 and class 3.1 substances. These regulations prescribe controls to reduce the likelihood of unintended ignition of Feliway Spray. 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 ERMA New Zealand Decision: Application HSR06088 Page 12 of 70 Control Code1 F11 F12 Regulation2 76 77 Explanation3 sources in an enclosure that will not allow the propagation of the flame to the outside; or using flameproof motors especially designed to prevent ignition energy escaping. It should be noted that any person handling any quantity of Feliway Spray 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 Feliway Spray, there is a requirement to ensure that the substance does not come into contact with any incompatible substance or material. There is also a requirement that packages of incompatible substances are held separately. Feliway Spray is 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 if flammable substances are present A hazardous substance location must be established, when Feliway Spray is held for a period exceeding either 18 hours. in quantities greater than: Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L F14 81 Quantity beyond which controls apply when use occurring in open containers 50 L 50 L 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 class 2.1.1, 2.1.2 or 3.1 substances are present There is a test certification requirement when Feliway Spray is present at any hazardous substance location when in quantities greater than: ERMA New Zealand Decision: Application HSR06088 Page 13 of 70 Control Code1 Regulation2 Explanation3 Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L F16 83 Quantity beyond which controls apply when use occurring in open containers 50 L 50 L That test certificate must be issued by an approved test certifier and must demonstrate compliance with a number of specified controls, including: ensuring that the responsible enforcement authority has been notified of the locality and capacity of the hazardous substance location; approved handler requirements; security requirements; hazardous atmosphere zone requirements, including controls on electrical systems and electrical equipment; segregation of incompatible substances; signage requirements; emergency management requirements, including fire-fighting equipment, emergency response plans and secondary containment; ensuring that a site plan is available for inspection. Controls on transit depots where flammable substances are present Transit depots are places designed to hold 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 Feliway Spray is held at a transit depot in quantities exceeding Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L Quantity beyond which controls apply when use occurring in open containers 50 L 50 L 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 Feliway Spray will be under the control of an approved handler; ensure that any road vehicle loaded with containers of Feliway Spray is not less than 3 m from any other vehicle or container containing compatible hazardous substances, and not less than 5 ERMA New Zealand Decision: Application HSR06088 Page 14 of 70 Control Code1 Regulation2 Explanation3 m from any other vehicle or container containing incompatible hazardous substances; ensure that containers of Feliway Spray held in the transit depot (but not loaded onto a vehicle) are not less than 5 m from containers of incompatible substances; ensure that Feliway Spray remains in its 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 toxic substances through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and it is a substance to which people are likely to be exposed to during their lifetime; and exposure is likely to result in an appreciable toxic effect. If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns. T2 T4/E6 29, 30 7 No ADE or TEL values are set for Feliway Spray 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 toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. The WES value set by the Department of Labour for Component D of Feliway Spray is to be adopted. Requirements for equipment used to handle hazardous substances Any equipment used to handle Feliway Spray (e.g. spray equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient ERMA New Zealand Decision: Application HSR06088 Page 15 of 70 Control Code1 Explanation3 information so that this can be achieved. T7 10 Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for public exposure to hazardous substances, the maximum quantity per package of Feliway Spray permitted to be carried on passenger service vehicles is 1 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 an ecotoxic substance legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition). An EEL can be established by one of three means: applying the default EELs specified; adopting an established EEL; calculating an EEL from an assessment of available ecotoxicological data. E2 Regulation2 46-48 No EEL values are set at this time for Feliway Spray. Restrictions on use within application area These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6, Regulation 9) do not apply once the substance has been applied or laid. In recognition of the need to limit adverse effects within the target area, Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. The application rate must not be greater than the application rate specified in the application for approval, or not greater than a rate calculated in a similar manner to that used to calculate EELs (with the proviso that the product of the uncertainty factors must not exceed 100). No maximum application rate is set for Feliway Spray at this time. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of Feliway Spray, in terms of: information that must be “immediately available” (i.e. priority and secondary identifiers), which is generally provided by way of the product label; documentation that must be available in the workplace, which is generally provided by way of SDS; ERMA New Zealand Decision: Application HSR06088 Page 16 of 70 Control Code1 I1 Regulation2 Explanation3 signage at a place where there is a large quantity of Feliway Spray. 6, 7, 32-35, 36 (1)-(7) General identification requirements These controls relate to the duties of suppliers and persons in charge of Feliway Spray 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 Feliway Spray 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 Feliway Spray must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds, e.g. on the label All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, e.g. on the label. Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily 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; ERMA New Zealand Decision: Application HSR06088 Page 17 of 70 Control Code1 Regulation2 I5 11 I9 18 I13 22 I16 25 Explanation3 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 flammable substances This requirement specifies that Feliway Spray must be prominently identified as being flammable. In addition, the following information must be provided: an indication that Feliway Spray is a liquid; and its general degree of flammability 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. Secondary identifiers for all hazardous substances This control relates to detail required on the product label for Feliway Spray. 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 flammable substances This control relates to the additional label detail required for Feliway Spray. 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 on the Feliway Spray label: an indication of its general type and degree of flammable hazard (e.g. highly flammable liquid); an indication of the circumstances in which it may be ignited unintentionally; an indication of the likely effect of an unintentional ignition; an indication of the steps to be taken to prevent an unintentional ignition. Secondary identifiers for toxic substances This control relates to the additional label detail required for toxic substances. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of toxic hazard (eg mild skin irritant); an indication of the circumstances in which it may harm human beings; ERMA New Zealand Decision: Application HSR06088 Page 18 of 70 Control Code1 Regulation2 I19 29-31 Explanation3 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. 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 Feliway Spray 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 Feliway Spray. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if Feliway Spray 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 Feliway Spray 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 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 Feliway Spray when 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 ERMA New Zealand Decision: Application HSR06088 Page 19 of 70 Control Code1 Regulation2 Explanation3 documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when Feliway Spray is held in the workplace in quantities equal to or greater than 1 L. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying Feliway Spray in quantities equal to or greater than 1 L to another person, 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 Feliway Spray is present in quantities equal to or greater than 1 L, 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 Feliway Spray belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with Feliway Spray must include the following information: the unequivocal identity of Feliway Spray (e.g. the CAS number, chemical name, common name, UN number, registered trade names); a description of the physical state, colour and odour of Feliway Spray; if the physical state of Feliway Spray 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 that Feliway Spray, 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 Ceva Animal Health New Zealand Limited; all emergency management and disposal information required for Feliway Spray; the date on which the documentation was prepared. 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 Feliway Spray. ERMA New Zealand Decision: Application HSR06088 Page 20 of 70 Control Code1 Regulation2 Explanation3 Regulation 48 – Location and presentation requirements for documentation All required documentation must be available to a person handling Feliway Spray 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 0.3 m. 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 Feliway Spray is being transported. I25 43 I28 46 I29 51-52 Regulation 50 – Documentation to be supplied on request Notwithstanding Regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where a hazardous substance is present) if asked to do so by that person. Specific documentation requirements for flammable substances The documentation provided with Feliway Spray 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 Feliway Spray 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 ERMA New Zealand Decision: Application HSR06088 Page 21 of 70 Control Code1 Regulation2 Explanation3 content, presentation and positioning at places where Feliway Spray is held in quantities exceeding 250 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for Feliway Spray 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 Feliway Spray 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 Feliway Spray, account must be taken of its physical state and properties, and packaging must be selected that complies with the requirements of Regulation 5, and Regulations 9 to 21. ERMA New Zealand Decision: Application HSR06088 Page 22 of 70 Control Code1 Regulation2 Explanation3 Regulation 8 – Compatibility Feliway Spray 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 Feliway Spray in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. P3 P5 P13 9 11 19 “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 Feliway Spray Feliway Spray that is packaged in quantities of more than 1 L must be packaged according to Schedule 2 (UN PGII, but must be packaged according to Schedule 2 or 4 when in quantities equal to or less than 1 L. Packages containing less than 0.1 L of Feliway Spray do not have to comply with the drop test performance standard contained in Schedule 4 provided the packaging complies with the requirements of regulations 5(1) (a), (b) and (e), and there is a warning statement on the outside of the package that the package may not withstand a drop of 0.5 m [Regulation 9 (3), (4), and (5)]. Feliway Spray that is offered for sale in a package of less than 2.5L 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. PG2 Schedule 2 This schedule describes the (minimum) packaging requirements that must be complied with for Feliway Spray when packaged in quantities of more than 1 L. The tests in Schedule 2 correlate to the packaging requirements of UN Packing Group II (UN PGII). PS4 Schedule 4 This schedule describes the minimum packaging requirements that must be complied with for Feliway Spray when packaged in quantities equal to or less than 1 L. Hazardous Substances (Disposal) Regulations 2001 D2 6 Disposal requirements for Feliway Spray D4 8 Feliway Spray must be disposed of by: D5 9 treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to discharge to the environment; or ERMA New Zealand Decision: Application HSR06088 Page 23 of 70 Control Code1 Regulation2 D6 10 D7 11, 12 D8 13, 14 Explanation3 exporting the substance from New Zealand as a hazardous waste. However, there is provision for Feliway Spray to be discharged into the environment as waste or deposited in a landfill, provided the discharge location is managed so that: the substance will not at any time come into contact with any substances with explosive or oxidising properties; and there is no ignition source in the vicinity of the disposal site; and in the event of an accidental fire, harm to people or the environment does not occur – the performance requirements for this are set out in Regulation 6(3)(b) of the Disposal Regulations. 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. Disposal requirements for packages This control gives the disposal requirements for packages that contained Feliway Spray 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 Feliway Spray that exceeds 0.1 L. Where a substance triggers more than one hazard classification, the most stringent quantity generally applies. 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 Feliway Spray that exceeds 1 L. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in Regulations 48(2), (3) and (4) of the Identification Regulations (code I21). ERMA New Zealand Decision: Application HSR06088 Page 24 of 70 Control Code1 Regulation2 Explanation3 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 Feliway Spray 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)). EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. Information requirements for toxic substances The following information must be provided when Feliway Spray is present in quantities equal to or greater than 0.1 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 when Feliway Spray is present in quantities equal to or greater than 0.1 L: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment. Level 2 emergency management documentation requirements These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Safety Data Sheets). This documentation must be provided where Feliway Spray is sold or supplied, or held in a workplace, in quantities equal to or greater than 1 L. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. 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 ERMA New Zealand Decision: Application HSR06088 Page 25 of 70 Control Code1 Regulation2 EM9 17 EM10 21-24 EM11 EM12 25-34 35-41 Explanation3 required by the Identification regulations (code I21). Specific documentation requirements for flammable substances There is an additional requirement for Feliway Spray 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 Feliway Spray is held in a place of work in quantities greater than 250 L, must have two fire extinguishers (Regulation 21). The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching hazardous substances, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of hazardous substances. Each fire extinguisher must be located within 30m of the substance, or, in a transportation situation, in or on the vehicle (Regulation 22). The performance measure for an extinguisher is that it must be capable of extinguishing a fully ignited pool of flammable liquid (50mm deep and at least 6m2 in area), before the extinguisher is exhausted, and when used by one person (Regulation 23). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where hazardous substances are held (or reasonably likely to be held on occasion) in quantities greater than 1000 L. The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be included in the plan is specified in Regulations 29 to 30. Requirements relating to the availability of equipment, materials and people are provided in Regulation 31, requirements regarding the availability of the plan are provided in Regulation 32 and requirements for testing the plan are described in Regulation 33. Level 3 emergency management requirements – secondary containment These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where Feliway Spray is held in quantities equal to or greater than 1000 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 ERMA New Zealand Decision: Application HSR06088 Page 26 of 70 Control Code1 Regulation2 EM13 42 Explanation3 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 250 L. The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the Identification Regulations. Hazardous Substances (Personnel Qualification) Regulations 2001 AH1 4-6 Approved Handler requirements Feliway Spray is required to be under the control of an approved handler as specified by control F4. An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances. Regulation 4 describes the test certification requirements, regulation 5 describes the qualification (competency and skill) requirements and regulation 6 describes situations where transitional qualifications for approved handlers apply. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable applicable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Section 77A Additional Controls The controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances, as set out in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are proposed for this substance, notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10. ERMA New Zealand Decision: Application HSR06088 Page 27 of 70 Table A1.2: Controls for Feliway Diffuser – codes and explanations Control Code4 Regulation5 Explanation6 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 Feliway Diffuser through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and it is a substance to which people are likely to be exposed to during their lifetime; and exposure is likely to result in an appreciable toxic effect. If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns. T2 29, 30 T4, E6 7 T7 10 No TEL values are set for Feliway Diffuser 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 toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. No WES values are set for Feliway Diffuser at this time. Requirements for equipment used to handle hazardous substances Any equipment used to handle Feliway Diffuser (e.g. spray equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved. Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for public exposure to Feliway Diffuser, the maximum quantity per package permitted to be carried on passenger service vehicles is 10 L, as specified in Schedule 2 of the Classes 6, 8 and 9 Control Regulations. 4 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 5 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. 6 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. ERMA New Zealand Decision: Application HSR06088 Page 28 of 70 Control Code4 Regulation5 Explanation6 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 Feliway Diffuser 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. E2 46-48 No EEL values are set for Feliway Diffuser at this time and the requirement to set default EELs is deleted. Restrictions on use within application area These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6, Regulation 9) do not apply once the substance has been applied or laid. In recognition of the need to limit adverse effects within the target area, Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. The application rate must not be greater than the application rate specified in the application for approval, or not greater than a rate calculated in a similar manner to that used to calculate EELs (with the proviso that the product of the uncertainty factors must not exceed 100). No maximum application rate is set for Feliway Diffuser at this time. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of hazardous substances in terms of: information that must be “immediately available” with the substance (priority and secondary identifiers). This information is generally provided by way of the product label; documentation that must be available in the workplace, generally provided by way of SDS; signage at a place where there is a large quantity of the substance. I1 6, 7, 32-35, 36 General identification requirements (1)-(7) These controls relate to the duties of suppliers and persons in ERMA New Zealand Decision: Application HSR06088 Page 29 of 70 Control Code4 Regulation5 Explanation6 charge of Feliway Diffuser 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 Feliway Diffuser 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 Feliway Diffuser must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds, e.g. on the label All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, e.g. on the label. Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily 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 ERMA New Zealand Decision: Application HSR06088 Page 30 of 70 Control Code4 Regulation5 I8 14 I9 18 I16 25 I19 29-31 Explanation6 under the normal conditions of storage, handling and use. Priority identifiers for certain toxic substances This requirement specifies that Feliway Diffuser (other than if it is NOT intended to be sold to the general public) must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance, 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. Secondary identifiers for all hazardous substances This control relates to detail required for Feliway Diffuser 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 toxic substances This control relates to the additional label detail required for Feliway Diffuser. 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, aspiration hazard); 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. 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 Feliway Diffuser are contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near ERMA New Zealand Decision: Application HSR06088 Page 31 of 70 Control Code4 Regulation5 Explanation6 the container, information that identifies the type and general degree of hazard of the substance. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if Feliway Diffuser are 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 Feliway Diffuser 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. I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for Feliway Diffuser 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 Feliway Diffuser is held in the workplace in quantities equal to or greater than 5 L, as specified in Schedule 2 of the Identification Regulations. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity of Feliway Diffuser equal to or greater than 5 L, as specified in Schedule 2 for that classification, if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person. ERMA New Zealand Decision: Application HSR06088 Page 32 of 70 Control Code4 Regulation5 Explanation6 Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where Feliway Diffuser is present in quantities equal to or greater than 5 L, as 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 Feliway Diffuser must include the following information: the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); a description of the physical state, colour and odour of the substance; if the substance’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the changes in physical state may occur and the nature of those changes; in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur; contact details for the New Zealand supplier / manufacturer /importer; all emergency management and disposal information required for the substance; the date on which the documentation was prepared; 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 substances 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. ERMA New Zealand Decision: Application HSR06088 Page 33 of 70 Control Code4 Regulation5 I23 41 I28 46 I29 51-52 Explanation6 Regulation 49 – Documentation requirements for vehicles This Regulation provides for the option of complying with documentation requirements as specified in the various Land, Sea and Air transport rules when the substance is being transported. Regulation 50 – Documentation to be supplied on request Notwithstanding Regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where a hazardous substance is present) if asked to do so by that person. Specific documentation requirements for ecotoxic substances The documentation provided with Feliway Diffuser must include the following information: its general degree and type of ecotoxic hazard (e.g. highly ecotoxic in the aquatic environment); a full description of the circumstances in which it may harm living organisms and the extent of that harm; a full description of the steps to be taken to prevent harm to living organisms; a summary of the available acute and chronic (ecotox) data used to define the (ecotox) subclass or subclasses in which it is classified; its bio-concentration factor or octanol-water partition coefficient; its expected soil or water degradation rate; any EELs set by the Authority. Specific documentation requirements for toxic substances The documentation provided with Feliway Diffuser 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. These requirements are triggered for Feliway Diffuser when held in ERMA New Zealand Decision: Application HSR06088 Page 34 of 70 Control Code4 Regulation5 Explanation6 quantities exceeding 100 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). I30 53 Advertising corrosive and toxic substances Any advertisement for Feliway Diffuser (other than it they are NOT intended to be sold to members of the public) 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. Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for Feliway Diffuser 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 Feliway Diffuser 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. ERMA New Zealand Decision: Application HSR06088 Page 35 of 70 Control Code4 Regulation5 Explanation6 Regulation 7(1) – Requirements when packing hazardous substance When packing Feliway Diffuser 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 Feliway Diffuser 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 Feliway Diffuser in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. P3 P13 P15 9 19 21 “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 Feliway Diffuser Feliway Diffuser must be packaged according to Schedule 3 (UN PGIII) when in quantities of more than 5 L, but must be packaged according to either Schedule 3 or Schedule 4 when in quantities equal to or less than 5 L. Feliway Diffuser 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 the substance 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 5 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 5 L. Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for Feliway Diffuser Feliway Diffuser must be disposed of by: treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to discharge to the environment; or discharging the substance to the environment provided that after reasonable mixing, the concentration of the substance in ERMA New Zealand Decision: Application HSR06088 Page 36 of 70 Control Code4 Regulation5 D6 10 D7 11, 12 D8 13, 14 Explanation6 any part of the environment outside the mixing zone does not exceed any TEL (tolerable exposure limit) or any EEL (environmental exposure limit) set by the Authority for that substance; or exporting the substance from New Zealand as a hazardous waste. Disposal requirements for packages This control gives the disposal requirements for packages that contained Feliway Diffuser 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 Feliway Diffuser that exceeds 0.1 L, as specified in Schedule 1 of the Disposal Regulations. Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, 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 Feliway Diffuser that exceeds 5 L, as specified in Schedule 2 of the Disposal Regulations. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in 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 Feliway Diffuser when present in quantities equal to or greater than 0.1 L, as listed in Schedule 1 of the Emergency Management Regulations. Regulation 6 describes the duties of suppliers, Regulation 7 describes the duties of persons in charge of places, Regulation 9 describes the requirement for the availability of the information (10 ERMA New Zealand Decision: Application HSR06088 Page 37 of 70 Control Code4 Regulation5 EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Explanation6 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 Feliway Diffuser is present in quantities equal to or greater than 1 L, as specified in Schedule 1 of the Emergency Management Regulations: 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 Feliway Diffuser when present in quantities equal to or greater than 0.1 L, as listed in Schedule 1 of the Emergency Management Regulations: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment. 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 Feliway Diffuser are sold or supplied, or held in a workplace, in quantities equal to or greater than 5 L, as specified in Schedule 2 of the Emergency Management Regulations. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM11 25-34 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where 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. ERMA New Zealand Decision: Application HSR06088 Page 38 of 70 Control Code4 Regulation5 Explanation6 These requirements are triggered for Feliway Diffuser when they are held in quantities greater than 100 L. EM12 35-41 The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be included in the plan is specified in Regulations 29 to 30. Requirements relating to the availability of equipment, materials and people are provided in Regulation 31, requirements regarding the availability of the plan are provided in Regulation 32 and requirements for testing the plan are described in Regulation 33. Level 3 emergency management requirements – secondary containment These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where liquid (or liquefiable) hazardous substances are held in quantities equal to or greater than those specified in Schedule 4 of the Emergency Management Regulations. These requirements are triggered for Feliway Diffuser when they are held in quantities equal to or greater than 100 L. EM13 42 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). 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. These requirements are triggered for Feliway Diffuser when they are held in quantities equal to or greater than 100 L. The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the Identification Regulations. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable applicable Containers) Regulations 2004 prescribe a number of controls ERMA New Zealand Decision: Application HSR06088 Page 39 of 70 Control Code4 Regulation5 Explanation6 relating to tank wagons and transportable containers and must be complied with as relevant. Additional Controls set under s77A NonSchedule 8, The controls relating to stationary container systems, as set out in flammable DGTN March Schedule 8 of the Hazardous Substances (Dangerous Goods and liquids 2004 Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, shall apply to this substance, notwithstanding clause 1(1) of that schedule. ERMA New Zealand Decision: Application HSR06088 Page 40 of 70 Table A1.3: Controls for DAP Spray – codes and explanations Control Code7 Regulation8 Explanation9 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property Controls F1 7 General test certification requirements for all class 1 to 5 substances Where a test certificate is required for a hazardous substance location holding flammable substances, that test certificate must be issued by an approved test certifier and must typically be renewed yearly. However, the Authority can, on request by the persons required to obtain the test certificate, extend the time period to three years. F2 8 General public transportation restrictions and requirements for DAP Spray The maximum quantity per package of DAP Spray permitted to be carried on passenger service vehicles is 1 L. F3 55 General limits on flammable substances Where DAP Spray is present at a place for longer than 18 hours, and in a quantity that exceeds the levels as follows, that substance must be held at a hazardous substance location or transit depot as appropriate: Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L F4 56 Quantity beyond which controls apply when use occurring in open containers 50 L 50 L Approved handler requirements When DAP Spray is held in quantities greater than: 250 L (when in containers greater than 5 L) 500 L (when in containers up to an including 5 L) it must generally be under the personal control of an approved handler or secured to a specified standard. However, the substance may be handled by a person who is not an approved handler if: the approved handler has provided guidance to the person in respect of handling; and the approved handler is available at all times to provide assistance if necessary. F5 58-59 It should be noted that any person handling any quantity of DAP Spray 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)]. Requirements for hazardous atmosphere zones for class 2.1.1, class 2.1.2 and class 3.1 substances. There is a requirement to establish a hazardous atmosphere zone 7 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 8 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. 9 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. ERMA New Zealand Decision: Application HSR06088 Page 41 of 70 Control Code7 Regulation8 Explanation9 wherever DAP Spray is present in quantities greater than: 100 L (closed) 25 L (decanting) 5 L (open occasionally) 1 L (if open container for continuous use) The zone must comply with either of the AS/NZS Standards as listed in Regulation 58(a)-(b) or with an ERMA approved code of practice. F6 F11 60-70 76 Regulation 59 discusses the application of other legislation with respect to electrical systems located within a hazardous atmosphere zone. Specifically, any controls placed on electrical systems or electrical equipment within a hazardous atmosphere zone must be consistent with any controls on such systems/equipment set under other legislation if they are relevant to that specific location. This is to ensure that any potential ignition sources from electrical system or electrical equipment are protected or insulated to an extent that is consistent with the degree of hazard. Requirements to reduce the likelihood of unintended ignition of class 2.1.1, class 2.1.2 and class 3.1 substances. These regulations prescribe controls to reduce the likelihood of unintended ignition of DAP Spray. 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. It should be noted that any person handling DAP Spray 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 DAP Spray, there is a requirement to ensure that the substance does not come into contact with any incompatible substance or material. There is also a requirement that packages of incompatible substances are held ERMA New Zealand Decision: Application HSR06088 Page 42 of 70 Control Code7 F12 Regulation8 77 Explanation9 separately. DAP Spray is 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 if flammable substances are present There is a requirement to establish a hazardous substance location where DAP Spray is present in quantities greater than Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L Quantity beyond which controls apply when use occurring in open containers 50 L 50 L and held for a period exceeding either 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 class 2.1.1, 2.1.2 or 3.1 substances are present There is a test certification requirement when DAP Spray is present at any hazardous substance location when in quantities greater than those specified in the table below: Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L Quantity beyond which controls apply when use occurring in open containers 50 L 50 L 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 ERMA New Zealand Decision: Application HSR06088 Page 43 of 70 Control Code7 Regulation8 F16 83 Explanation9 location; approved handler requirements; security requirements; hazardous atmosphere zone requirements, including controls on electrical systems and electrical equipment; segregation of incompatible substances; signage requirements; emergency management requirements, including fire-fighting equipment, emergency response plans and secondary containment; ensuring that a site plan is available for inspection. Controls on transit depots where flammable substances are present Transit depots are places designed to hold 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 DAP Spray is held at a transit depot in quantities exceeding Quantity beyond which controls apply for closed containers 100 L in containers greater than 5 L 250 L in containers up to an including 5 L Quantity beyond which controls apply when use occurring in open containers 50 L 50 L 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 DAP Spray will be under the control of an approved handler; ensure that any road vehicle loaded with containers of DAP Spray 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 DAP Spray held in the transit depot (but not loaded onto a vehicle) are not less than 5 m from containers of incompatible substances; ensure that DAP Spray remains in its 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 toxic substances through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally ERMA New Zealand Decision: Application HSR06088 Page 44 of 70 Control Code7 Regulation8 Explanation9 allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and it is a substance to which people are likely to be exposed to during their lifetime; and exposure is likely to result in an appreciable toxic effect. T2 29, 30 No TELs are set for DAP Spray 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 toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. The WES value set by the Department of Labour for Component H of DAP Spray is adopted. T4 7 Requirements for equipment used to handle hazardous E6 7 substances Any equipment used to handle toxic substances (e.g. spray equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved. T7 10 Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for public exposure to DAP Spray the maximum quantity per package of DAP Spray permitted to be carried on passenger service vehicles is 1 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 an ecotoxic substance legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition). An EEL can be established by one of three means: applying the default EELs specified; adopting an established EEL; calculating an EEL from an assessment of available ecotoxicological data. No EEL values are set at this time for DAP Spray. ERMA New Zealand Decision: Application HSR06088 Page 45 of 70 Control Code7 E2 Regulation8 46-48 Explanation9 Restrictions on use within application area These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6, Regulation 9) do not apply once the substance has been applied or laid. In recognition of the need to limit adverse effects within the target area, Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. The application rate must not be greater than the application rate specified in the application for approval, or not greater than a rate calculated in a similar manner to that used to calculate EELs (with the proviso that the product of the uncertainty factors must not exceed 100). No maximum application rate is set for DAP Spray at this time. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of hazardous substances in terms of: information that must be “immediately available” with the substance (priority and secondary identifiers). This information is generally provided by way of the product label; documentation that must be available in the workplace, generally provided by way of SDS; signage at a place where there is a large quantity of the substance. I1 6, 7, 32-35, 36 General identification requirements (1)-(7) These controls relate to the duties of suppliers and persons in charge of DAP Spray 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 DAP Spray 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 DAP Spray (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulation 7 – Identification duties of persons in charge Persons in charge of any hazardous substance must ensure it is labelled ERMA New Zealand Decision: Application HSR06088 Page 46 of 70 Control Code7 Regulation8 Explanation9 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. I5 I8 11 14 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 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 flammable substances This requirement specifies that DAP Spray must be prominently identified as being flammable. In addition, the following information must be provided: an indication of that the product is a 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 a class DAP Spray must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance, 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 ERMA New Zealand Decision: Application HSR06088 Page 47 of 70 Control Code7 Regulation8 Explanation9 label. I9 18 I13 Regulation 22 I16 25 I19 29-31 Secondary identifiers for all hazardous substances This control relates to detail required for DAP Spray 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 flammable substances This control relates to the additional label detail required for DAP Spray. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of flammable hazard (e.g. highly flammable liquid); an indication of the circumstances in which it may be ignited unintentionally; an indication of the likely effect of an unintentional ignition; 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 DAP Spray. 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. Alternative information in certain cases Regulation 29 – Substances in fixed bulk containers or bulk transport containers This Regulation relates to alternative ways of presenting the priority and secondary identifier information required by Regulations 8 to 25 when substances are contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the ERMA New Zealand Decision: Application HSR06088 Page 48 of 70 Control Code7 Regulation8 Explanation9 substance. When class 1, 2, 3, 4 or 5 substances are contained, there is an additional requirement that information must be provided describing any steps to be taken to prevent an unintentional explosion, ignition combustion, acceleration of fire or thermal decomposition. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if the substance is labelled or marked in compliance with the requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. Regulation 30 – Substances in multiple packaging This Regulation relates to situations when DAP Spray 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. I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for DAP Spray 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 DAP Spray is held in the workplace in quantities equal to or greater than 1 L. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity of DAP Spray equal to or greater than 1 L, if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where DAP Spray is present in quantities equal to or greater than those specified in Regulation 38 ERMA New Zealand Decision: Application HSR06088 Page 49 of 70 Control Code7 Regulation8 Explanation9 (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 DAP Spray must include the following information: the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); a description of the physical state, colour and odour of the substance; if the substance’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the changes in physical state may occur and the nature of those changes; in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur; contact details for the New Zealand supplier / manufacturer /importer; all emergency management and disposal information required for the substance; the date on which the documentation was prepared. 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. Regulation 50 – Documentation to be supplied on request Notwithstanding Regulation 37 above, a supplier must provide the ERMA New Zealand Decision: Application HSR06088 Page 50 of 70 Control Code7 Regulation8 I23 41 I25 43 I28 46 I29 51-52 Explanation9 required documentation to any person in charge of a place of work (where a hazardous substance is present) if asked to do so by that person. Specific documentation requirements for ecotoxic substances The documentation provided with DAP Spray must include the following information: its general degree and type of ecotoxic hazard (e.g. highly ecotoxic to terrestrial vertebrates); a full description of the circumstances in which it may harm living organisms and the extent of that harm; a full description of the steps to be taken to prevent harm to living organisms; a summary of the available acute and chronic (ecotox) data used to define the (ecotox) subclass or subclasses in which it is classified; its bio-concentration factor or octanol-water partition coefficient; its expected soil or water degradation rate; any EELs set by the Authority. Specific documentation requirements for flammable substances The documentation provided with DAP Spray 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 DAP Spray must include the following information: its general degree and type of toxic hazard; a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; a full description of the steps to be taken to prevent harm to human beings; if it will be a liquid during its use, the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured; a summary of the available acute and chronic (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 DAP Spray is held in quantities exceeding 100 L. ERMA New Zealand Decision: Application HSR06088 Page 51 of 70 Control Code7 Regulation8 Explanation9 Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). I30 53 Advertising corrosive and toxic substances Any advertisement for DAP Spray 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. Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for DAP Spray 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 DAP Spray 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 DAP Spray, account must be taken of its physical state ERMA New Zealand Decision: Application HSR06088 Page 52 of 70 Control Code7 Regulation8 Explanation9 and properties, and packaging must be selected that complies with the requirements of Regulation 5, and Regulations 9 to 21. Regulation 8 – Compatibility DAP Spray 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 DAP Spray in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. “Large Packaging” does not include: P3 P5 P13 P15 9 11 19 21 a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004; or a stationary container system, a stationary tank or a tank (as defined in the Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for DAP Spray DAP Spray in quantities over 1 L must be packaged according to Schedule 2 (UN PGII), but must be packaged according to either Schedule 2 or Schedule 4 when in quantities equal to or less than 1 L. PG2 Schedule 2 PS4 Schedule 4 Packages containing less than 0.1L of DAP Spray do not have to comply with the drop test performance standard contained in Schedule 4 provided the packaging complies with the requirements of regulations 5(1) (a), (b) and (e), and there is a warning statement on the outside of the package that the package may not withstand a drop of 0.5m [Regulation 9 (3), (4), and (5)]. Any DAP Spray that is offered for sale in a package of less than 2.5L 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 DAP Spray when packaged in quantities of more than 1 L. The tests in Schedule 2 correlate to the packaging requirements of UN Packing Group II (UN PGII). This schedule describes the minimum packaging requirements that must be complied with for DAP Spray when packaged in quantities equal to or less than 1 L. Hazardous Substances (Disposal) Regulations 2001 D2 6 Disposal requirements for DAP Spray D4 8 DAP Spray must be disposed of by: D5 9 treating the substance so that it is no longer a hazardous substance. exporting the substance from New Zealand as a hazardous waste ERMA New Zealand Decision: Application HSR06088 Page 53 of 70 Control Code7 Regulation8 D6 10 D7 11, 12 D8 13, 14 Explanation9 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 o there is no ignition source in the vicinity of the disposal site, and o 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 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 DAP Spray 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 DAP Spray that exceeds 0.1 L. 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 DAP Spray that exceeds 1 L. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in Regulations 48(2), (3) and ERMA New Zealand Decision: Application HSR06088 Page 54 of 70 Control Code7 Regulation8 Explanation9 (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 DAP Spray 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)). EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. Information requirements for toxic substances The following information must be provided when DAP Spray is present in quantities equal to or greater than 0.1 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 DAP Spray when present in quantities equal to or greater than 0.1 L: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment. Level 2 emergency management documentation requirements These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Safety Data Sheets). This documentation must be provided where DAP Spray is sold or supplied, or held in a workplace, in quantities equal to or greater than 1 L. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. 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). ERMA New Zealand Decision: Application HSR06088 Page 55 of 70 Control Code7 EM9 Regulation8 17 EM10 21-24 EM11 EM12 25-34 35-41 Explanation9 Specific documentation requirements for flammable and oxidising substances and organic peroxides There is an additional requirement for DAP Spray 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 DAP Spray is held in a place of work in quantities exceeding 250 L, must have two fire extinguishers (Regulation 21). The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching hazardous substances, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of hazardous substances. Each fire extinguisher must be located within 30m of the substance, or, in a transportation situation, in or on the vehicle (Regulation 22). The performance measure for an extinguisher is that it must be capable of extinguishing a fully ignited pool of flammable liquid (50mm deep and at least 6m2 in area), before the extinguisher is exhausted, and when used by one person (Regulation 23). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where DAP Spray 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 DAP Spray 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 ERMA New Zealand Decision: Application HSR06088 Page 56 of 70 Control Code7 Regulation8 EM13 42 Explanation9 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 DAP Spray is held at quantities equal to or greater than 100 L. The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the Identification Regulations. Hazardous Substances (Personnel Qualification) Regulations 2001 AH1 4-6 Approved Handler requirements DAP Spray is required to be under the control of an approved handler as specified by control F4. An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances. Regulation 4 describes the test certification requirements, regulation 5 describes the qualification (competency and skill) requirements and regulation 6 describes situations where transitional qualifications for approved handlers apply. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable applicable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notices Flammable Schedules 8, 9 The controls relating to stationary container systems, secondary Liquids and 10 DGTN containment and unintended ignition of flammable substances, as set March 2004 out in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, shall apply to this substance, notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10. ERMA New Zealand Decision: Application HSR06088 Page 57 of 70 Table A1.4: Controls for DAP Diffuser – codes and explanations Control Code10 Regulation11 Explanation12 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 DAP Diffuser through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and it is a substance to which people are likely to be exposed to during their lifetime; and exposure is likely to result in an appreciable toxic effect. If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns. T2 29, 30 T4, E6 7 T7 10 No TEL values are set for DAP Diffuser 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 toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. No WES values are set for DAP Diffuser at this time. Requirements for equipment used to handle hazardous substances Any equipment used to handle DAP Diffuser (e.g. spray equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved. Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for public exposure to DAP Diffuser, the maximum quantity per package permitted to be carried on passenger service vehicles is 10 L, as specified in Schedule 2 of the Classes 6, 8 and 9 Control Regulations. 10 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. 11 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. 12 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. ERMA New Zealand Decision: Application HSR06088 Page 58 of 70 Control Code10 Regulation11 Explanation12 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 DAP Diffuser 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. E2 46-48 No EEL values are set for DAP Diffuser at this time and the requirement to set default EELs is deleted. Restrictions on use within application area These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6, Regulation 9) do not apply once the substance has been applied or laid. In recognition of the need to limit adverse effects within the target area, Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. The application rate must not be greater than the application rate specified in the application for approval, or not greater than a rate calculated in a similar manner to that used to calculate EELs (with the proviso that the product of the uncertainty factors must not exceed 100). No maximum application rate is set for DAP Diffuser at this time. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of hazardous substances in terms of: information that must be “immediately available” with the substance (priority and secondary identifiers). This information is generally provided by way of the product label; documentation that must be available in the workplace, generally provided by way of SDS; signage at a place where there is a large quantity of the substance. I1 6, 7, 32-35, 36 General identification requirements (1)-(7) These controls relate to the duties of suppliers and persons in charge of DAP Diffuser with respect to identification (essentially ERMA New Zealand Decision: Application HSR06088 Page 59 of 70 Control Code10 Regulation11 Explanation12 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 DAP Diffuser 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 DAP Diffuser must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulations 32 and 33 – Accessibility of information All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds, e.g. on the label All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds, e.g. on the label. Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily 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. ERMA New Zealand Decision: Application HSR06088 Page 60 of 70 Control Code10 I8 Regulation11 14 I9 18 I16 25 I19 29-31 Explanation12 Priority identifiers for certain toxic substances This requirement specifies that DAP Diffuser (other than if it is NOT intended to be sold to the general public) must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance, 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. Secondary identifiers for all hazardous substances This control relates to detail required for DAP Diffuser 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 toxic substances This control relates to the additional label detail required for DAP Diffuser. 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, aspiration hazard); 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. 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 DAP Diffuser are contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance. Regulation 29(2) specifies that for bulk transport containers, it is ERMA New Zealand Decision: Application HSR06088 Page 61 of 70 Control Code10 Regulation11 Explanation12 sufficient compliance if DAP Diffuser are 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 DAP Diffuser are in multiple packaging and the outer packaging obscures some or all of the required substance information. In such cases, the outer packaging must: be clearly labelled with all relevant priority identifier information i.e. the hazardous properties of the substance must be identified; or be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant; or in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background); or bear the relevant class or subclass label assigned by the UN Model Regulations. I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for DAP Diffuser 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 DAP Diffuser is held in the workplace in quantities equal to or greater than 5 L, as specified in Schedule 2 of the Identification Regulations. Regulation 37 – Documentation duties of suppliers A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person a quantity of DAP Diffuser equal to or greater than 5 L, as specified in Schedule 2 for that classification, if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where DAP Diffuser is ERMA New Zealand Decision: Application HSR06088 Page 62 of 70 Control Code10 Regulation11 Explanation12 present in quantities equal to or greater than 5 L, as 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 DAP Diffuser must include the following information: the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); a description of the physical state, colour and odour of the substance; if the substance’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the changes in physical state may occur and the nature of those changes; in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur; contact details for the New Zealand supplier / manufacturer /importer; all emergency management and disposal information required for the substance; the date on which the documentation was prepared; 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 substances 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. ERMA New Zealand Decision: Application HSR06088 Page 63 of 70 Control Code10 Regulation11 I23 41 I28 46 I29 51-52 Explanation12 Regulation 50 – Documentation to be supplied on request Notwithstanding Regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where a hazardous substance is present) if asked to do so by that person. Specific documentation requirements for ecotoxic substances The documentation provided with DAP Diffuser must include the following information: its general degree and type of ecotoxic hazard (e.g. highly ecotoxic in the aquatic environment); a full description of the circumstances in which it may harm living organisms and the extent of that harm; a full description of the steps to be taken to prevent harm to living organisms; a summary of the available acute and chronic (ecotox) data used to define the (ecotox) subclass or subclasses in which it is classified; its bio-concentration factor or octanol-water partition coefficient; its expected soil or water degradation rate; any EELs set by the Authority. Specific documentation requirements for toxic substances The documentation provided with DAP Diffuser 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. These requirements are triggered for DAP Diffuser when held in quantities exceeding 100 L. Signs are required: at every entrance to the building and/or location (vehicular and ERMA New Zealand Decision: Application HSR06088 Page 64 of 70 Control Code10 Regulation11 Explanation12 pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). I30 53 Advertising corrosive and toxic substances Any advertisement for DAP Diffuser (other than it they are NOT intended to be sold to members of the public) 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. Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for DAP Diffuser 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 DAP Diffuser 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 DAP Diffuser account must be taken of its physical state and properties, and packaging must be selected that complies ERMA New Zealand Decision: Application HSR06088 Page 65 of 70 Control Code10 Regulation11 Explanation12 with the requirements of Regulation 5, and Regulations 9 to 21. Regulation 8 – Compatibility DAP Diffuser 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 DAP Diffuser in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. P3 P13 P15 9 19 21 “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 DAP Diffuser DAP Diffuser must be packaged according to Schedule 3 (UN PGIII) when in quantities of more than 5 L, but must be packaged according to either Schedule 3 or Schedule 4 when in quantities equal to or less than 5 L. Packages containing less than 0.5L of DAP Diffuser do not have to comply with the drop test performance standard contained in Schedule 4 provided the packaging complies with the requirements of regulation 5(1) (a), (b) and (e), and there is warning statement on the outside of the package that the package may not withstand a drop of 0.5m [Regulation 9 (3), (4) and (5)]. DAP Diffuser 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 the substance 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 5 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 5 L. Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for DAP Diffuser DAP Diffuser must be disposed of by: treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of the substance with any other substance prior to ERMA New Zealand Decision: Application HSR06088 Page 66 of 70 Control Code10 Regulation11 D6 10 D7 11, 12 D8 13, 14 Explanation12 discharge to the environment; or discharging the substance to the environment provided that after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone does not exceed any TEL (tolerable exposure limit) or any EEL (environmental exposure limit) set by the Authority for that substance; or exporting the substance from New Zealand as a hazardous waste. Disposal requirements for packages This control gives the disposal requirements for packages that contained DAP Diffuser 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 DAP Diffuser that exceeds 0.1 L, as specified in Schedule 1 of the Disposal Regulations. Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided 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 DAP Diffuser that exceeds 5 L, as specified in Schedule 2 of the Disposal Regulations. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in 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 DAP Diffuser when present in quantities equal to or greater than 0.1 L, as listed in Schedule 1 of the Emergency Management Regulations. ERMA New Zealand Decision: Application HSR06088 Page 67 of 70 Control Code10 Regulation11 EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Explanation12 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 DAP Diffuser is present in quantities equal to or greater than 1 L, as specified in Schedule 1 of the Emergency Management Regulations: 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 DAP Diffuser when present in quantities equal to or greater than 0.1 L, as listed in Schedule 1 of the Emergency Management Regulations: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment. 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 DAP Diffuser are sold or supplied, or held in a workplace, in quantities equal to or greater than 5 L, as specified in Schedule 2 of the Emergency Management Regulations. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM11 25-34 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ERMA New Zealand Decision: Application HSR06088 Page 68 of 70 Control Code10 Regulation11 Explanation12 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. These requirements are triggered for DAP Diffuser when they are held in quantities greater than 100 L. EM12 35-41 The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be included in the plan is specified in Regulations 29 to 30. Requirements relating to the availability of equipment, materials and people are provided in Regulation 31, requirements regarding the availability of the plan are provided in Regulation 32 and requirements for testing the plan are described in Regulation 33. Level 3 emergency management requirements – secondary containment These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where liquid (or liquefiable) hazardous substances are held in quantities equal to or greater than those specified in Schedule 4 of the Emergency Management Regulations. These requirements are triggered for DAP Diffuser when they are held in quantities equal to or greater than 100 L. EM13 42 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). 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. These requirements are triggered for DAP Diffuser when they are held in 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. ERMA New Zealand Decision: Application HSR06088 Page 69 of 70 Control Code10 Regulation11 Explanation12 Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable applicable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Additional Controls set under s77A NonSchedule 8, The controls relating to stationary container systems, as set out in flammable DGTN March Schedule 8 of the Hazardous Substances (Dangerous Goods and liquids 2004 Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, shall apply to this substance, notwithstanding clause 1(1) of that schedule. ERMA New Zealand Decision: Application HSR06088 Page 70 of 70