ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 27 November 2006 Application Code HSR06116 Application Type To import or manufacture any hazardous substance under Section 28A(2)(a) of the Hazardous Substances and New Organisms Act 1996 Applicant Orion Crop Protection Ltd Purpose of the Application OCP 0601: This substance is a herbicidal product which is similar in formulation and properties to that of an existing substance. Approval of the substance as being similar to a substance with an existing HSNO approval is being sought. (similar) Date Application Received 27 October 2006 Consideration Date 24 November 2006 Considered by Rob Forlong (Chief Executive, ERMA New Zealand) 1 SUMMARY OF DECISION 1.1 The application to import or manufacture OCP 0601 is approved with the controls as set out in Appendix 1 in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the Act), the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology), based on its similar composition and similar hazardous properties to a substance that has been approved by the Authority. 1.2 For this approval, the substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: OCP 0601 2 LEGISLATIVE CRITERIA FOR APPLICATION 2.1 The application was lodged pursuant to section 28. The decision was determined in accordance with section 28A(2)(a), taking into account 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. Environmental Risk Management Authority Decision: Application HSR06116 Page 1 of 24 3 APPLICATION PROCESS 3.1 The purpose of the application is to gain approval to import or manufacture OCP 0601 for use as a herbicide. 3.2 The application was formally received on 27 October 2006. 3.3 The Agricultural Compounds & Veterinary Medicines Group (ACVMG) of the New Zealand Food Safety Authority (NZFSA), the Ministry of Health and the Department of Labour Workplace Group were advised of the application (clause 2(2)(e)). 3.4 No responses were received. 3.5 Evaluation of the application was undertaken by the ERMA New Zealand Project Team: 3.6 4 Margaret Keane Applications Advisor (Hazardous Substances) Sekove Tinalevu Science Advisor (Hazardous Substances) The application was considered by the Chief Executive of ERMA New Zealand as provided for by a delegation from the Authority under section 19(2)(d). CONSIDERATION Sequence of the consideration 4.1 Orion Crop Protection Ltd seeks approval under section 28A to import or manufacture the substance identified as OCP 0601. 4.2 Under section 28A(2)(a), an application can be assessed under rapid assessment procedures if it can be shown that a substance having a similar composition and similar hazardous properties has been approved by the Authority. Decision-making authority for such rapid assessments has been delegated to the Chief Executive of ERMA New Zealand (section 19(2)(d)). 4.3 The approach adopted when considering this application was: to identify the composition and hazardous properties of the proposed substance, OCP 0601, the reference similar substance nominated by Orion Crop Protection Ltd, and other potential reference substances; to determine whether OCP 0601 has a similar composition and similar hazardous properties to the nominated reference substance or another reference substance. 4.4 And then: to determine whether OCP 0601 has a similar life-cycle to the reference substance; to consider whether the risks posed by OCP 0601 are the same as, less than or greater than those posed by the reference substance; to consider whether there are any other effects which mean that OCP 0601 should not be rapidly assessed; and Environmental Risk Management Authority Decision: Application HSR06116 Page 2 of 24 taking into account the controls that apply under the Act to the reference substance, apply appropriate controls to OCP 0601. Information review 4.5 The project team has reviewed the information supplied by Orion Crop Protection Ltd and considers that the information constitutes an adequate and appropriate basis for considering the application (clause 8). They also consider that there are no significant uncertainties (i.e. sufficient to influence decision making) in the scientific and technical information relating to the risks of the substance (clauses 29 and 30). Identification of the reference substance 4.6 Orion Crop Protection Ltd identified a reference substance against which OCP 0601 should be compared. The reference substance identified was “Emulsifiable concentrate containing 100 - 170 g/litre picloram as the amine salt and 300 - 420 g/litre triclopyr as the butoxyethyl ester” with HSNO approval number HSR000553. 4.7 After considering the reference substance proposed by the applicant and other potential reference substances, the project team used as a reference substance that transferred under the Act on 1 July 2004 by way of the Hazardous Substance (Pesticide) Transfer Notice 2004, and given the descriptor “Emulsifiable concentrate containing 100 - 170 g/litre picloram as the amine salt and 300 - 420 g/litre triclopyr as the butoxyethyl ester” with the HSNO Approval Number HSR000553. Composition of OCP 0601 relative to that of the reference substance 4.8 Both OCP 0601 and the reference substance contain the same active components and are in the form of emulsifiable concentrates, but the excipients differ. Both products are formulated for dilution in water for end use. 4.9 The two active components and a diluent are the major hazardous components that confer the hazard classifications to OCP 0601; refer confidential appendix. 4.10 The concentration of one of the active ingredients in OCP 0601 is greater than in the reference substance. For the other active ingredient, the concentration is within the substance description of the reference substance. There are also some changes in the other excipients in the formulations but these do not have a significant influence on the nature or hazardous properties of the substance compared with the reference. The total concentration of major hazardous components is more in the reference substance than in OCP 0601. 4.11 The impurities contained in the active ingredients in the formulation of OCP 0601 do not present any concern in respect of the hazardous properties of the substance. 4.12 After taking the variations in composition into account, the project team considers that the compositions of OCP 0601 and the reference substance are of the same nature and kind. Accordingly, the project team is satisfied that OCP 0601 has a similar composition to the reference substance. Environmental Risk Management Authority Decision: Application HSR06116 Page 3 of 24 Hazardous properties of OCP 0601 relative to that of the reference substance 4.13 To be eligible for consideration under section 28A(2)(a), OCP 0601 must have similar hazardous properties to the reference substance. The hazardous properties of OCP 0601, as determined by the applicant and project team, and the reference substance are listed in Table 4.1. Table 4.1: Comparison of hazard classifications. OCP 0601 Hazard Endpoint Applicant Project Team Flammability Acute Toxicity (Oral) Acute Toxicity (Inhalation) Skin Irritation/Corrosion Eye Irritation/Corrosion Dermal Sensitisation Target Organ Toxicity Aquatic Ecotoxicity Soil Ecotoxicity Ecotoxic to terrestrial vertebrates 3.1D 6.1D 6.3B 6.4A 6.5B 6.9B 9.1A 9.2A 9.3C Reference substance 3.1D 6.1D 6.3B 6.4A 6.5B 6.9B 9.1A 9.2A 9.3C 3.1D 6.1D 6.1D 6.3B 6.4A 6.5B 6.9B 9.1A 9.2A 9.3C 4.14 It is noted that the hazard profiles proposed by the applicant and the project team are in agreement. 4.15 The project team’s determination of hazards indicates that there is a reduction in hazard profile from the reference substance to OCP 0601 due to the reduction in acute toxicity via the inhalation route. 4.16 The project team is of the view that OCP 0601 meets the criteria for similar hazardous properties given that OCP 0601 does not pose any new or increased hazards. Evaluation against the criteria for similar composition and similar hazardous properties 4.17 The project team is satisfied that, based on the application submitted by Orion Crop Protection Ltd, and on information available for the reference substance, the analysis in the preceding paragraphs shows that the criteria for similar composition and similar hazardous properties under section 28A(2)(a) have been met. Comparison of the use of OCP 0601 relative to that of the reference substance 4.18 Both the proposed and the reference substances are herbicides used for vegetation control in crop and non-crop situations. Both formulations contain the same active components. Both products are in the form of an emulsifiable concentrate. Both products are formulated for dilution in water for end use. 4.19 OCP 0601 will have the same use pattern and will be applied at exactly the same rate as the reference substance. Environmental Risk Management Authority Decision: Application HSR06116 Page 4 of 24 5 LIFE-CYCLE, RISKS AND CONTROLS 5.1 The applicant has advised the life-cycle details for OCP 0601 are as follows. 5.1.1 OCP 0601 will be formulated by a toll manufacturer accredited to ISO 9000:2000. Documented quality control procedures are in place, which cover matters such as the spillage, emergency procedures, and waste disposal. 5.1.2 Packaging will be in accordance with the Hazardous Substances (Packaging) Regulations 2001. Containers will be UN Approved HDPE jerry cans with tamper evident caps, with sizes ranging from 1 to 200 litres. Minimum packaging specification will be to UN packing group III. 5.1.3 Packaging will carry labelling in accordance with the Hazardous Substances (Labelling) Regulations 2001, including priority and secondary identifiers, and the Hazardous Substances (Emergency Management) Regulations 2001, including level 1 emergency information. 5.1.4 Storage at the manufacturing site will be in accordance with a location test certificate issued under the requirements of the HSNO regulations (Note: Not specifically required for this class of substance). Storage will be in accordance with the signage, emergency procedures and secondary containment requirements of the Hazardous Substances (Emergency Management) Regulations 2001. 5.1.5 Transport will be in accordance with NZS5433:1999 ‘Transport of Dangerous Goods by Land. As such, transport will be by trained and certified drivers, on trucks with suitable segregation, class quantities and placarding. A dangerous goods declaration will accompany each shipment. 5.1.6 If packed in outer packaging, that packaging will be labelled in accordance with the Hazardous Substances (Labelling) Regulations 2001, and the Hazardous Substances (Emergency Management) Regulations 2001. 5.1.7 OCP 0601 is a herbicide. Application will, in general, be by farmers and commercial contractors, via ground (knapsack or gun equipment) or aerial spraying. Application, use rates, crops, residues, etc, will be regulated for crop use by the ACVM Group of the New Zealand Food Safety Authority as part of registration conditions. The maximum application rate of the active ingredient component will be the same as the reference substance. 5.1.8 Disposal of the substance will be via its use, in accordance with the label directions. Empty containers will be triple rinsed, the rinsate being added to the spray tank for use. Containers are to be disposed of via an approved landfill, or agricultural recycling scheme. These directions are to be contained on the product label. 5.2 The assessment of the proposed substance’s lifecycle, risks and controls has not identified any other matters (section 6) that would prevent OCP 0601 from being approved by rapid assessment. 5.3 It is therefore considered that, given the similarities in composition, hazardous properties and the risks associated with the life-cycle, the controls prescribed by the Environmental Risk Management Authority Decision: Application HSR06116 Page 5 of 24 regulations should be applied to OCP 0601 with the same variations that were considered applicable to the reference substance. Additional controls under section 77A 5.4 The following controls are applied to OCP 0601 under section 77A: 5.4.1 The Hazardous Substances (Pesticides) (Amendment) Transfer Notice 2006 states that unless specifically allowed for, no pesticide may be applied onto or into water. As OCP 0601 is not approved for such use, the following control is applied to OCP 0601: OCP 0601 shall not be applied onto or into water. 5.4.2 As a means of managing the risks from OCP 0601, additional controls relating to stationary container systems and unintended ignition of flammable substances are required for this substance. Accordingly, the following controls are applied to OCP 0601: “The controls relating to stationary container systems and unintended ignition of flammable substances, as set out in Schedules 8 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 Schedule 8 and clause 1 of Schedule 10.” 5.4.3 Control code EM12 relates to level 3 emergency management requirements. It is noted that additional sub-clauses have been applied to the reference substance on transfer.. The Agency considers that these controls are relevant to OCP 0601, and notes that no other such controls have been specified under the Act. In accordance with section 77A(4)(a) of the Act, I consider 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 OCP 0601. 5.4.4 Accordingly, the following subclauses are added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. Environmental Risk Management Authority Decision: Application HSR06116 Page 6 of 24 5.5 The additional controls, as above, have been incorporated into the list of controls for OCP 0601 detailed in Appendix 1. Variation of controls under section 77 5.6 It is noted that changes may have been made in legislation subsequent to the approval of the reference substance. These regulatory changes now also apply to the reference substance (section 77(2)(a)). 5.7 The following variations shall apply to OCP 0601: 5.7.1 Control T1 relates to limiting exposure to toxic substances through the setting of Tolerable Exposure Limits (TELs). ERMA New Zealand is considering a range of issues to do with TELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. I note that TELs have not been set for the reference substance and consider that no TELs should be set at this time for OCP 0601. 5.7.2 Control T2 specifies requirements relating to workplace exposure standards (WESs). Under regulation 29(2) of the Hazardous Substance (Classes 6, 8, and 9 Controls) Regulations 2001, I adopt as a workplace exposure standard for component B (see confidential appendix) of this substance, the value which is specified in the document described in “Workplace Exposure Standards”, published by the Occupational Safety and Health Service, Department of Labour, January 2002, ISBN 0-477-03660-0. Also available at www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf. 5.7.3 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 Agency has not previously set an EEL for the reference substance, consequently, the Agency is not proposing that any EEL values be set for OCP 0601 until implementation of a pending comprehensive review of setting such values under section 77B of the Act. Consequently, no EEL is proposed at this time and the default EELs may be deleted under section 77(4)(a). 5.7.4 Control E2 relates to restrictions on use within an application area when and EEL has been set. As no EELs have been set, no application rates have been set at this time. 5.7.5 Controls E7 and AH1 both relate to the requirements for approved handlers. I note that these controls were varied for the reference substance. and I consider the same variation to be appropriate for OCP 0601. Accordingly, control E7 is varied so that the substance must be under the personal control of an approved handler when the substance is (a) applied in a wide dispersive manner; or (b) used by a commercial contractor. Environmental Risk Management Authority Decision: Application HSR06116 Page 7 of 24 5.7.6 Control TR1 relates to the requirement for records to be kept of the location and movement of OCP 0601. I note that this requirement was omitted for the reference substance. Because of the similarities in the substances, this requirement for OCP 0601 has been deleted. 5.7.7 Controls T4 and E6 are combined under section 77(5) as they both relate to requirements for equipment used to handle OCP 0601. 5.7.8 Controls T7 and F2 are combined under section 77(5) as they both relate to restrictions placed on the carriage of hazardous substances on passenger service vehicles. It is noted that T7 takes effect as it is the most stringent requirement. 5.7.9 Controls P3, P5, P13 and P15 are combined under section 77(5) as they all relate to packaging requirements for OCP 0601. 5.7.10 Controls D2, D4 and D5 are combined under section 77(5) as they all relate to disposal requirements for OCP 0601. 5.8 6 The modifications to controls, as above, have been incorporated into the list of controls for OCP 0601 detailed in Appendix 1. ENVIRONMENTAL USER CHARGES 6.1 Section 96 provides that the Authority may identify and report to the Minister where it considers that a reduction in the likely occurrence of adverse effects similar to that achieved by the controls attached to any substance could be achieved by any environmental user charge, or a combination of an environmental user charge and controls. 6.2 The project team considers that the use of controls is the most effective means of managing the risks throughout the life cycle of OCP 0601. The imposition of an environmental user charge instead of, or in combination with controls, is therefore not required at this time. 7 DECISION 7.1 Having considered the project team’s evaluation of the composition and hazardous properties of OCP 0601 and the reference substance, I am satisfied that this substance meets the criteria for rapid assessment under section 28A(2)(a) in that it has a similar composition and similar hazardous properties to an approved substance. 7.2 In considering OCP 0601 to be similar to an existing substance approved under the Act, in accordance with clause 36(2)(b), I have considered section 28A(2)(a) and also applied the following criteria in the Methodology: clause 9 – equivalent of sections 5, 6 and 8; clause 12 – evaluation of assessment of risks; clause 21 – the decision accords with the requirements of the Act and regulations; Environmental Risk Management Authority Decision: Application HSR06116 Page 8 of 24 clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; and clause 35 – the costs and benefits of varying the default controls. 7.3 Having regard for the controls applied to the reference substance, I am satisfied that the controls proposed in this document will be adequate to manage the adverse effects of OCP 0601. 7.4 The application for OCP 0601 is accordingly approved pursuant to section 28A(2)(a) with controls as listed in Appendix 1 Rob Forlong Chief Executive, ERMA New Zealand OCP 0601 ERMA New Zealand Approval Code: Date: 27 November 2006 HSR007677 Environmental Risk Management Authority Decision: Application HSR06116 Page 9 of 24 Appendix 1: Controls Applying to OCP 0601 The controls imposed on OCP 0601 are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New Zealand publication “User Guide to Control Regulations” provides useful guidance on the controls. Control Code1 Regulation2 Explanation3 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property Controls F2 8 General public transportation restrictions and requirements for all class 1 to 5 substances T7 10 The maximum quantity per package of OCP 0601 permitted to be carried (Hazardous on passenger service vehicles is 0.1 L. Substances (Classes 6, 8 and 9 Controls) Regulations 2001) F6 60-70 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 OCP 0601. Controls are prescribed with the aim of covering all foreseeable circumstances in which unintended ignition could take place, and include: placing limits on the proportion of flammable vapour to air to ensure that the proportion of flammable vapour to air will always be sufficiently outside the flammable range, so that ignition cannot take place; and ensuring that there is insufficient energy available for ignition. This energy could be in the form of either temperature or ignition energy (e.g. a spark). Accordingly, the controls provide two approaches to ensure that there is insufficient energy for ignition: (1) keeping the temperature of the substance, or the temperature of any surface in contact with the substance, below 80% of the autoignition temperature of the substance, and (2) keeping sources of ignition below the minimum ignition energy, either by removal of the ignition source from any location where flammable substances are handled, or by protecting the “general” mass of flammable material from the ignition source, e.g. by enclosing any ignition sources in an enclosure that will not allow the propagation of the flame to the outside; or using flameproof motors especially designed to prevent ignition energy escaping. It should be noted that any person handling any quantity of OCP 0601 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)]. 1 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. 3 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. Environmental Risk Management Authority Decision: Application HSR06116 Page 10 of 24 Control Code1 F11 Regulation2 76 Explanation3 Segregation of incompatible substances In order to reduce the likelihood of unintended ignition of OCP 0601, there is a requirement to ensure that it does not come into contact with any incompatible substance or material. There is also a requirement that packages of incompatible substances are held separately. A list of substances and materials considered incompatible with OCP 0601 follows: All class 1 substances; All class 2 substances; Class 3.2 substances; All class 4 substances; All class 5 substances. This regulation does not apply to OCP 0601 that is 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. 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. T2 29, 30 T4, E6 7 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. No TELs are set for OCP 0601 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. WESs have been adopted and set for Component B in OCP 0601. Note: the WES value for component B is listed in “Workplace Exposure Standards”, published by the Occupational Safety and Health Service, Department of Labour, January 2002, ISBN 0-477-03660-0. Requirements for equipment used to handle hazardous substances Any equipment used to handle OCP 0601 (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. Environmental Risk Management Authority Decision: Application HSR06116 Page 11 of 24 T5 8 Requirements for protective clothing and equipment Protective clothing/equipment must be employed when OCP 0601 is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with OCP 0601 and is not directly exposed to a concentration of OCP 0601that is greater than the WES for that substance. The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing/equipment may be used, and the requirements for maintaining the clothing/equipment. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 Limiting exposure to ecotoxic substances This control relates to the setting of environmental exposure limits (EELs). An EEL establishes the maximum concentration of 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 EELs are set for OCP 0601 at this time. E2 46-48 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. E5 5(2), 6 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 Application Rates are set for OCP 0601 at this time. Requirements for keeping records of use A person using OCP 0601 for the purposes of causing biocidal action must keep written records of that use if 3 kg or more of the substance is applied within 24 hours in an area where the substance is likely to enter air or water and leave the place. The information to be provided in the record is described in Regulation 6(1). The record must be kept for a minimum of three years following the use and must be made available to an enforcement officer on request. Environmental Risk Management Authority Decision: Application HSR06116 Page 12 of 24 E7 9 Approved handler requirements Regulation 9(1) is replaced by: (1) This hazardous substance must be under the personal control of an approved handler when the substance is— (a) applied in a wide dispersive manner; or (b) used by a commercial contractor However, OCP 0601 may be handled by a person who is not an approved handler if: an approved handler is present at the facility where the substance is being handled; and the approved handler has provided guidance to the person in respect of handling; and the approved handler is available at all times to provide assistance if necessary. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of OCP 0601 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, General identification requirements 36 (1)-(7) These controls relate to the duties of suppliers and persons in charge of OCP 0601 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 OCP 0601 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 OCP 0601 (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulation 7 – Identification duties of persons in charge Persons in charge of any hazardous substance must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information 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 Environmental Risk Management Authority Decision: Application HSR06116 Page 13 of 24 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. I3 I5 I8 9 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 ecotoxic substances This requirement specifies that OCP 0601 must be prominently identified as being ecotoxic. This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for flammable substances This requirement specifies that OCP 0601 must be prominently identified as being flammable. In addition, the following information must be provided: an indication that OCP 0601 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 OCP 0601 must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance (unless it is used in a place of work where the general public may not lawfully be present), and the need to restrict access to the substance by children. This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. I9 18 Secondary identifiers for all hazardous substances This control relates to detail required for OCP 0601 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: Environmental Risk Management Authority Decision: Application HSR06116 Page 14 of 24 I11 20 I13 Regulation 22 I16 25 I17 26 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 ecotoxic substances This control relates to the additional label detail required for OCP 0601. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of the circumstances in which it may harm living organisms; an indication of the kind and extent of the harm it is likely to cause to living organisms; an indication of the steps to be taken to prevent harm to living organisms; an indication of its general type and degree of hazard (i.e. very ecotoxic in the aquatic environment, very ecotoxic in the soil environment, harmful to terrestrial vertebrates). Secondary identifiers for flammable substances This control relates to the additional label detail required for OCP 0601. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of flammable hazard (e.g. flammable liquid); an indication of the circumstances in which it may be ignited unintentionally; an indication of the likely effect of an unintentional ignition; an indication of the steps to be taken to prevent an unintentional ignition. Secondary identifiers for toxic substances This control relates to the additional label detail required for OCP 0601. 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 (ie acutely toxic, irritating to the skin, irritating to the eye, a contact sensitiser, harmful to human target organs or systems); an indication of the circumstances in which it may harm human beings; an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm; an indication of the steps to be taken to prevent harm to human beings; the name and concentration of components A, B and F. Use of Generic Names This control provides the option of using a generic name to identify groups of ingredients where such ingredients are required to be listed on the product label as specified by Regulations 25 (e) and (f). A generic name may also be used to identify a specific ingredient required by Regulation 25(f) to be identified, if section 55 or section 57 of the Act Environmental Risk Management Authority Decision: Application HSR06116 Page 15 of 24 applies (withholding information on confidentiality grounds). The generic name must identify the key chemical entities and functional groups in the ingredients that contribute to their hazardous properties. I18 I19 27 29-31 [Regulations 25 (e) and (f) specify a requirement to list on the product label, the name of components A, B and F]. Use of Concentration Ranges This control provides the option of providing concentration ranges for those ingredients whose concentrations are required to be stated on the product label as specified by Regulations 25(e) and (f). [Regulations 19(f) and 25(e) and (f) specify a requirement to list on the product label, the concentration of components A, B and F]. Alternative information in certain cases Regulation 29 – Substances in fixed bulk containers or bulk transport containers This Regulation relates to alternative ways of presenting the priority and secondary identifier information required by Regulations 8 to 25 when substances are contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance. When OCP 0601 is contained, there is an additional requirement that information must be provided describing any steps to be taken to prevent an unintentional explosion, ignition combustion, acceleration of fire or thermal decomposition. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if the substance is labelled or marked in compliance with the requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. Regulation 30 – Substances in multiple packaging This Regulation relates to situations when OCP 0601 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. Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for OCP 0601 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. Environmental Risk Management Authority Decision: Application HSR06116 Page 16 of 24 I20 36(8) I21 37-39, 47-50 Durability of information for class 6.1 substances Any packaging in direct contact with OCP 0601 must be permanently identified as having contained a toxic substance, unless the substance as packaged is restricted to a place of work. Documentation required in places of work These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets) (Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when OCP 0601 is held in the workplace in quantities equal to or greater 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 OCP 0601 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 OCP 0601 is hazardous substances are present in quantities equal to or greater than those specified in Regulation 38 (and with reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation required for each hazardous substance concerned. The person in charge must also ensure that the documentation does not contain any information that suggests that the substance belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with OCP 0601 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; the name, concentration and CAS number of components A, B and F. Environmental Risk Management Authority Decision: Application HSR06116 Page 17 of 24 Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (e.g. as provided on an SDS). If information required by Regulations 39 to 46 was not included in the information used for the approval of the substance by the Authority, it is sufficient compliance with those Regulations if reference is made to that information requirement along with a comment indicating that such information is not applicable to that substance. Regulation 48 – Location and presentation requirements for documentation All required documentation must be available to a person handling the substance in a place of work within 10 minutes. The documentation must be readily understandable by any fully-trained worker required to have access to it and must be easily read, under normal lighting conditions, at a distance of not less than 0.3m. Regulation 49 – Documentation requirements for vehicles This Regulation provides for the option of complying with documentation requirements as specified in the various Land, Sea and Air transport rules when the substance is being transported. I23 41 I25 43 I28 46 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 OCP 0601 must include the following information: its general degree and type of ecotoxic hazard (i.e. very ecotoxic in the aquatic environment, very ecotoxic in the soil environment, harmful to terrestrial vertebrates); a full description of the circumstances in which it may harm living organisms and the extent of that harm; a full description of the steps to be taken to prevent harm to living organisms; a summary of the available acute and chronic (ecotox) data used to define the (ecotox) subclass or subclasses in which it is classified; its bio-concentration factor or octanol-water partition coefficient; its expected soil or water degradation rate; any EELs set by the Authority. Specific documentation requirements for flammable substances The documentation provided with OCP 0601 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 OCP 0601 must include the following information: its general degree and type of toxic hazard (ie acutely toxic, irritating Environmental Risk Management Authority Decision: Application HSR06116 Page 18 of 24 I29 51-52 to the skin, irritating to the eye, a contact sensitiser, harmful to human target organs or systems); a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; a full description of the steps to be taken to prevent harm to human beings; the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured; a summary of the available acute and chronic (toxicity) data used to define the (toxic) subclass or subclasses in which it is classified; the symptoms or signs of injury or ill health associated with each likely route of exposure; the dose, concentration, or conditions of exposure likely to cause injury or ill health; any TELs or WESs set by the Authority. Duties of persons in charge of places with respect to signage These controls specify the requirements for signage, in terms of content, presentation and positioning at places where OCP 0601 is held in quantities exceeding 100 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). I30 53 Advertising toxic substances Any advertisement for OCP 0601must include information that identifies the substance is toxic and indicates the need to restrict access by children. In addition, it must specify the general degree and type of hazard (unless it is used in a place of work where members of the public may not lawfully be present). Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements 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 OCP 0601 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. Environmental Risk Management Authority Decision: Application HSR06116 Page 19 of 24 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 OCP 0601 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 OCP 0601, 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 OCP 0601 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 OCP 0601 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, P15 9, 11, 19, 21 PG3 Schedule 3 PS4 Schedule 4 “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004; or a stationary container system, a stationary tank or a tank (as defined in the Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for substances packed in limited quantities OCP 0601 packaged in quantities over 5 L must be packaged according to Schedule 3 (UN PGIII), but must be packaged according to either Schedule 3 or Schedule 4 when in quantities equal to or less than 5 L. OCP 0601 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. 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). 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. Environmental Risk Management Authority Decision: Application HSR06116 Page 20 of 24 Hazardous Substances (Disposal) Regulations 2001 D2, D4, 6, 8, 9 Disposal requirements for OCP 0601 D5 OCP 0601 must be disposed of by: treating OCP 0601 so that it is no longer a hazardous substance. exporting OCP 0601 from New Zealand as a hazardous waste treatment can include controlled burning providing the performance requirements as set out in regulation 6 (3)(b) of the Disposal Regulations for protecting people and the environment are met, and the burning operation does not exceed any TELs or EELs treatment includes discharge into the environment as waste, or depositing in a landfill, provided the discharge location is managed so that: OCP 0601 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, and after reasonable mixing, the concentration of OCP 0601 in any part of the environment outside the mixing zone does not exceed the 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 D6 10 Disposal requirements for packages This control gives the disposal requirements for packages that contained OCP 0601 and are no longer to be used for that purpose. Such packages must be either decontaminated/treated or rendered incapable of containing any substance (hazardous or otherwise) and then disposed of in a manner that is consistent with the disposal requirements for the substance. In addition, the manner of disposal must take into account the material that the package is manufactured from. D7 11, 12 Disposal information requirements These controls relate to the provision of information concerning disposal (essentially on the label) that must be provided when selling or supplying a quantity of OCP 0601 that exceeds 0.1 L. D8 13, 14 Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, i.e. that would not comply with the Disposal Regulations. Such information must be accessible to a person handling 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 OCP 0601 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). Environmental Risk Management Authority Decision: Application HSR06116 Page 21 of 24 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 OCP 0601 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 OCP 0601 is present in quantities equal to or greater than 0.l 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 OCP 0601 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 OCP 0601 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. EM9 17 EM10 21-24 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Specific documentation requirements for flammable substances There is an additional requirement for OCP 0601 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 OCP 0601 is held in a place of work in quantities exceeding 500 L, must have two fire extinguishers (Regulation 21). The intention of these general requirements is to provide sufficient Environmental Risk Management Authority Decision: Application HSR06116 Page 22 of 24 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 OCP 0601. EM11 EM12 25-34 35-41 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 OCP 0601 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 OCP 0601 held in quantities equal to or greater than 100 L. Regulation 36 prescribes requirements for secondary containment systems for pooling substances. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60 L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60 L and 450 L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450 L. Regulation 40 prescribes requirements for places where hazardous substances are held underground. Regulation 41 prescribes requirements for secondary containment systems that contain substances of specific hazard classifications, e.g. there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained). The following subclauses are to be added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. Environmental Risk Management Authority Decision: Application HSR06116 Page 23 of 24 (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. EM13 42 Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where OCP 0601 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 OCP 0601 is required to be under the control of an approved handler when applied in a wide dispersive manner or used by a commercial contractor (see Control E7). An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances. Regulation 4 describes the test certification requirements, regulation 5 describes the qualification (competency and skill) requirements and regulation 6 describes situations where transitional qualifications for approved handlers apply. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 The Hazardous Substances (Tank Wagons and Transportable Containers) where applicable Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Additional Controls applied under s77A Schedules 8 and 10, The controls relating to unintended ignition of flammable liquids, as set out DGTN March 2004 in Schedules 8 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 Schedule 8 and clause 1 of Schedule 10. OCP 0601 shall not be applied into or onto water. Variation of the EM12 control. Environmental Risk Management Authority Decision: Application HSR06116 Page 24 of 24