ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 16 April 2007 Application code: HSR07033 Application type Importation or manufacture of a hazardous substance for release under Section 28A(2)(c) the Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act) Applicant: Osmose NZ Ltd Purpose of the application PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use: to seek approval to import or manufacture for use as timber treatments (reduced hazard) Date application received: 28 March 2007 Consideration date 13 April 2007 Considered by Rob Forlong (Chief Executive, ERMA New Zealand) 1 Summary of decision 1.1 The application to import or manufacture PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use for release is approved with the controls as set out in Appendix 1. This approval has been given in accordance with the relevant provisions of the Act, the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology), based on PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use being formulated so that 1 or more of the hazardous properties assigned to the substances has a lesser degree of hazard than a substance approved under the Act. 1.2 The substances have been given the following unique identifiers for the ERMA New Zealand Hazardous Substances Register: PROTIM Aquazole Concentrate PROTIM Aquazole Ready-to-use 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)(c), taking into account the requirements of 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. 3 Application process 3.1 The purpose of this application is to gain approval to import or manufacture PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use for release as timber treatments. 3.2 The application was formally received on 28 March 2007. 3.3 The Department of Labour Workplace Group was advised of the application (clause 2(2)(e)). 3.3.1 3.4 3.5 No response was received. Evaluation of the application was undertaken by the ERMA New Zealand project team which comprised the following staff members: Margaret Keane Advisor (Hazardous Substances) Sekove Tinalevu Advisor (Hazardous Substances) Beth Dye Applications Manager (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). 4 Consideration Sequence of the consideration 4.1 Osmose NZ Ltd seeks approval, under section 28, to import or manufacture PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use for release in New Zealand as timber treatments. 4.2 A substance can be assessed by rapid assessment procedures, under section 28A(2)(c), if it can be shown that it has been formulated so that one or more of its hazardous properties has a lesser degree of hazard than any substance already approved under the Act. 4.3 The approach adopted when considering this application was: to identify the composition and hazardous properties of the proposed substances, PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use, and of a reference substance; to determine whether the reference substance is one that has been approved by the Authority and whether the proposed substances have been formulated so that one or more of the hazardous properties assigned to them has a lesser degree of hazard than the reference substance. 4.4 And then: to determine whether the proposed substances have a similar use to the reference substance; to consider whether the risks posed by the proposed substances are the same as, less than or greater than those posed by the reference substance; to consider whether there are any other effects that mean the proposed substances should not be rapidly assessed; and Environmental Risk Management Authority Decision: Application HSR07033 Page 2 of 40 to consider whether the controls that apply under the Act will adequately prevent or manage the adverse effects of the proposed substances. Information review 4.5 The project team has reviewed the information supplied by Osmose NZ Ltd, and considers that the information constitutes an adequate and appropriate basis for assessing the application (clause 8). They also consider that there are no significant uncertainties (ie sufficient to influence decision making) in the scientific and technical information relating to the risks of PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use (clauses 29 and 30). Identification of the reference substance 4.6 The applicant identified a reference substance with which they consider PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use may be compared. 4.7 However, the project team considers a different reference substance approved under the Act by the Authority to be more appropriate. Due to reasons of confidentiality, the identity of the reference substance cannot be disclosed in this document. Composition of PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use relative to that of the reference substance 4.8 PROTIM Aquazole Concentrate, PROTIM Aquazole Ready-to-use and the reference substance are all in a liquid form. PROTIM Aquazole Concentrate and the reference substance are both liquid concentrates, requiring dilution prior to use. 4.9 The major hazardous components conferring the hazard classifications to PROTIM Aquazole Concentrate are the three active ingredients (propiconazole, tebuconazole and permethrin), and components D1 and E. The major hazardous components conferring the hazard classifications to PROTIM Aquazole Ready-to-use are permethrin and components D and E. The active ingredients and other excipients are the major hazardous components conferring the hazard classifications to the reference substance. 4.10 The total concentration of major hazardous components is greater in PROTIM Aquazole Concentrate than in the reference substance. However, the project team considers this increase to be within acceptable limits. The total concentration of major hazardous components is greater in the reference substance than in PROTIM Aquazole Ready-to-use. Hazardous properties of PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use relative to that of the reference substance 4.11 The project team has determined the hazard profile of PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use based on the information provided by the applicant and other available information. The hazard classifications for PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use are set out in Table 4.1 for comparison against the reference substance. refer to Confidential Appendix 3 for a key to component identity Environmental Risk Management Authority Decision: Application HSR07033 1 Page 3 of 40 Table 4.1: Comparison of hazard classifications Hazard Endpoint PROTIM Aquazole Concentrate 3.1D Flammability 6.1E Acute Toxicity (Oral) Acute Toxicity (Dermal) Acute Toxicity (Inhalation) 6.3B Skin Irritation/Corrosion 6.4A Eye Irritation/Corrosion 6.5A Inhalation Sensitisation 6.5B Dermal Sensitisation 6.9B Target Organ Toxicity 9.1A Aquatic Ecotoxicity Ecotoxicity to terrestrial vertebrates 9.4B Ecotoxicity to terrestrial invertebrates PROTIM Aquazole Ready-to-use 6.3B 6.4A 6.5A 6.5B 9.1A 9.4B Reference substance 3.1C 6.1D 6.1C 6.1D 6.3B 6.4A 6.5A 6.5B 6.9B 9.1A 9.3C 9.4B 4.12 The project team notes that, compared with the reference substance, PROTIM Aquazole Concentrate does not trigger the 6.1C (dermal) and 6.1D (inhalation) acute toxicity classifications or the 9.3C ecotoxic classification. PROTIM Aquazole Concentrate also has reduced flammability and acute toxicity (oral) classifications. 4.13 The project team also notes that, compared with the reference substance, PROTIM Aquazole Ready-to-use does not trigger a flammability classification, an acute toxicity classification, a target organ toxicity classification or a 9.3 ecotoxicity classification. 4.14 The reduction in hazard profile of PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use when compared with the reference substance is due to the presence of excipients in the reference substance which are not present in PROTIM Aquazole Concentrate or in PROTIM Aquazole Ready-to-use. 4.15 An additional reduction in hazard profile of PROTIM Aquazole Ready-to-use when compared with the reference substance is due to a reduction in the concentration of active ingredients. Meeting the criteria for rapid assessment under section 28A(2)(c) 4.16 Based on the reduced hazard profiles detailed above, the project team considers that the criteria for rapid assessment under section 28A(2)(c) have been met through PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use being formulated so that one or more of the hazardous properties assigned to the substances has a lesser degree of hazard than a substance that has been approved under the Act. Use of the proposed substances relative to the reference substance 4.17 PROTIM Aquazole Concentrate is in a liquid concentrate form and PROTIM Aquazole Ready-to-use is in a liquid ready-to-use form. Like PROTIM Aquazole Concentrate, the reference substance is a liquid concentrate which requires dilution prior to use. All three substances are only available for sale to industrial timber vacuum/pressure impregnation plants. 4.18 PROTIM Aquazole Concentrate may be sold to timber treatment facilities for dilution on site with water before impregnation or may be used to prepare the PROTIM Aquazole Ready–to–use Solution for delivery by bulk tanker. There is also the option Environmental Risk Management Authority Decision: Application HSR07033 Page 4 of 40 of manufacturing the Ready-to-use solution from the component materials rather than by dilution of the concentrate. 5 Controls 5.1 For the purposes of clarity, consideration of the default controls, additional controls conferred under section 77A and controls variations made under section 77 has been made separately to each substance in Paragraphs 5.2 to 5.15 for PROTIM Aquazole Concentrate and Paragraphs 5.16 to 5.29 for PROTIM Aquazole Ready-to-use. For similar reasons, a separate controls matrix has been prepared for each substance in Appendix 1 (PROTIM Aquazole Concentrate) and Appendix 2 (PROTIM Aquazole Ready-to-use). PROTIM Aquazole Concentrate Default controls 5.2 Based on the hazard classifications determined for the PROTIM Aquazole Concentrate, a set of associated default controls has been identified by the project team as being applicable. These default controls, expressed as control codes1, are listed in Table 5.1. 5.3 Additional controls under section 77A are available to manage the risks associated with PROTIM Aquazole Concentrate, which are not addressed by the default controls. These are considered in Paragraph 5.10 of this decision. 5.4 As the proposed substance has a reduced hazard profile when compared to the reference substance, some of the controls assigned to the reference substance (F1, F3, F5, F12, F14, F16, T3, T6, E4 and I20) are not applicable. As both products have the same use pattern, the remaining controls are the same other than some minor labelling differences and changes to some trigger quantities. 5.5 The project team notes that controls, T8 (controls for vertebrate poisons), E2 (restrictions on use of substances in application areas), E3 (controls relating to protection of terrestrial invertebrates) and E5 (requirements for keeping records of use) have been triggered for PROTIM Aquazole Concentrate on the basis of its intrinsic hazards. However, these controls were not considered relevant based on the substance’s use as a timber treatment and have therefore not been listed. Table 5.1: List of default controls for PROTIM Aquazole Concentrate Flammability Controls F2 Restrictions on the carriage of flammable substances on passenger service vehicles F6 Requirements to prevent unintended ignition of class 3.1 substances F11 Segregation of incompatible substances Toxicity Controls T1 Limiting exposure to toxic substances through the setting of TELs T2 Controlling exposure in places of work through the setting of WESs. T4 Requirements for equipment used to handle substances T5 Requirements for protective clothing and equipment T7 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A detailed list of these codes is contained in the ERMA New Zealand User Guide to the Controls Regulations. Environmental Risk Management Authority Decision: Application HSR07033 Page 5 of 40 1 Ecotoxicity Controls E1 Limiting exposure to ecotoxic substances through the setting of EELs E6 Requirements for equipment used to handle substances E7 Approved handler/security requirements for certain ecotoxic substances Identification Controls I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability I3 Priority identifiers for ecotoxic substances I5 Priority identifiers for flammable substances I8 Priority identifiers for toxic substances I9 Secondary identifiers for all hazardous substances I11 Secondary identifiers for ecotoxic substances I13 Secondary identifiers for flammable substances I16 Secondary identifiers for toxic substances I17 Use of generic names I18 Requirements for using concentration ranges I19 Additional information requirements, including situations where substances are in multiple packaging I21 General documentation requirements I23 Specific documentation requirements for ecotoxic substances I25 Specific documentation requirements for flammable substances I28 Specific documentation requirements for toxic substances I29 Signage requirements I30 Advertising corrosive and toxic substances Packaging Controls P1 General packaging requirements P3 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria P5 Packaging requirements for flammable liquids P13 Packaging requirements for toxic substances P15 Packaging requirements for ecotoxic substances PG3 Packaging requirements equivalent to UN Packing Group III PS4 Packaging requirements as specified in Schedule 4 Disposal Controls D2 Disposal requirements for flammable substances D4 Disposal requirements for toxic substances D5 Disposal requirements for ecotoxic substances D6 Disposal requirements for packages D7 Information requirements for manufacturers, importers and suppliers, and persons in charge D8 Documentation requirements for manufacturers, importers and suppliers, and persons in charge Emergency Management Controls EM1 Level 1 information requirements for suppliers and persons in charge EM6 Information requirements for toxic substances EM7 Information requirements for ecotoxic substances EM8 Level 2 information requirements for suppliers and persons in charge EM9 Additional information requirements for flammable and oxidising substances and organic peroxides EM10 Fire extinguisher requirements EM11 Level 3 emergency management requirements: duties of person in charge, emergency response plans EM12 Level 3 emergency management requirements: secondary containment EM13 Level 3 emergency management requirements: signage Environmental Risk Management Authority Decision: Application HSR07033 Page 6 of 40 Tracking Controls TR1 General tracking requirements Approved Handler Controls AH1 Approved Handler requirements (including test certificate and qualification requirements) Tank Wagon and Transportable Containers Controls The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers. Setting of exposure limits and application rates 5.6 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 relating to TELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. The project team notes that TELs have not been set for the reference substance and therefore proposes that no TELs should be set at this time for PROTIM Aquazole Concentrate. 5.7 Control T2 relates to the requirement to set Workplace Exposure Standards (WESs). Under regulation 29(2) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001, the project team proposes as a workplace exposure standard for component E, the value or values 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. 5.8 Control E1 relates to limiting exposure to ecotoxic substances through the setting of Environmental Exposure Limits (EELs). ERMA New Zealand is considering a range of issues relating to EELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. The project team notes that EELs have not been set for the reference substance and therefore proposes that no EELs should be set at this time for PROTIM Aquazole Concentrate and that the default EELwater be deleted. Additional controls under section 77A 5.9 Under section 77A, the Authority may impose as controls any obligations and restrictions that the Authority thinks fit. Before imposing a control under this section, the Authority must be satisfied that, against any other specified controls applying to PROTIM Aquazole Concentrate: (a) the proposed control is more effective in terms of its effect on the management, use and risks of hazardous substances; or (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of hazardous substances; or (c) the proposed control is more likely to achieve its purpose. 5.10 The project team considers that the following controls are applicable to PROTIM Aquazole Concentrate as discussed below: 5.10.1 The project team notes that the assessment of PROTIM Aquazole Concentrate has been based solely upon the substance being used as a timber treatment but none of the default controls limits how the substance may be used. Accordingly, the Agency considers that the following control should be applied to PROTIM Aquazole Concentrate as it will be more effective than Environmental Risk Management Authority Decision: Application HSR07033 Page 7 of 40 the specified (default) controls in terms of its effect on the management, use and risks of the substance: PROTIM Aquazole Concentrate shall only be used as an agent in the preservation treatment of timber at industrial sites. 5.10.2 The project team notes that the specified controls do not address the risks associated with stationary container systems, they do not allow for dispensation where it is unnecessary for any associated pipework to have secondary containment and they do not address the risks relating to adverse effects of unintended ignition of the substance. Accordingly, the project team considers that the application of controls addressing these risks will be more effective than the specified (default) controls in terms of their effect on the management, use and risks of the substance. Such controls were applied to timber treatments on transfer to the HSNO regime. The project team considers that these controls are similarly appropriate for the management of the risks associated with PROTIM Aquazole Concentrate and proposes that the following controls should be applied to the substance: 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, shall apply to this substance, notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10. 5.10.3 The project team considers that the following subclauses should be added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001 (control EM12): (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. Variation of controls under section 77 5.11 Under section 77, the default controls triggered for the substance may be varied. Under section 77(3), controls may be substituted or added. Under section 77(4), controls may be substituted or deleted. Under section 77(5), where a substance triggers more than one hazard classification, controls may be combined. 5.12 The Agency considers that the following controls should be varied under section 77(4)(b) for PROTIM Aquazole Concentrate, as the variations will not significantly increase the adverse effects of the substance: Environmental Risk Management Authority Decision: Application HSR07033 Page 8 of 40 5.12.1 Controls F2 and T7 relate to requirements for carriage of substances on passenger service vehicles. The trigger quantity that would normally apply for a substance with the hazard classification of PROTIM Aquazole Concentrate is 0.1 L, as driven by the sensitisation classification. However, the project team notes that the trigger quantity for sensitisation was varied for pesticides transferred to the Act under the Hazardous Substances (Pesticides) Transfer Notice 2004, from 0.1 L to I L. Consequently, the Agency considers that the quantity of PROTIM Aquazole Concentrate triggering this requirement should likewise be increased to 1 L. 5.12.2 Controls E7, AH1 and TR1 relate to tracking requirements for PROTIM Aquazole Concentrate triggered as a result of its 9.1A classification. As this substance will not be used in a wide dispersive manner, the project team consider that the approved handler controls can be deleted as provided by section 77(4)(b). Further, where the tracking controls have been triggered solely as a result of ecotoxicity, it is considered that any risks arising during the substance’s life-cycle are adequately managed by other controls such as packaging, labelling and emergency management requirements. The project team therefore proposes that the tracking controls be deleted as provided by section 77(4)(b). This approach is consistent with the Authority’s policy on approved handler and tracking controls for class 9 substances (November 2003). 5.12.3 Control I16 (Regulation 25 of the Hazardous Substances (Identification) Regulations 2001) relates to requirements for identifying on the substance label every ingredient that would, independently of any other ingredient, give PROTIM Aquazole Concentrate a hazard classification of 6.5 and 6.9. The project team considers that Components A and B which would, independently of any other ingredients, cause PROTIM Aquazole Concentrate to be classified as a 6.9B substance, do not require identification on the substance label because of their low concentration in the formulation. However, the project team considers that this variation should only apply to the substance label and that documentation requirements required by control I21 (Regulation 39 of the Hazardous Substances (Identification) Regulations 2001) should apply as though control I16 has not been varied. 5.12.4 Accordingly, the labelling requirements for PROTIM Aquazole Concentrate are as follows: Labelling requirement component C 5.13 Documentation requirement component A component B component C The Agency considers that the following controls may be combined under section 77(5) for PROTIM Aquazole Concentrate as they relate to the same requirements: 5.13.1 Controls T4 and E6 which relate to requirements for equipment used to handle PROTIM Aquazole Concentrate. 5.13.2 Controls P3, P5, P13 and P15 which relate to packaging requirements for PROTIM Aquazole Concentrate. Environmental Risk Management Authority Decision: Application HSR07033 Page 9 of 40 5.13.3 Controls D2, D4 and D5 which relate to disposal requirements for PROTIM Aquazole Concentrate. 5.14 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)). 5.15 The modifications to controls, as above, have been incorporated into the list of controls for PROTIM Aquazole Concentrate detailed in Appendix 1. PROTIM Aquazole Ready-to-use Default controls 5.16 Based on the hazard classifications determined for the PROTIM Aquazole Ready-to-use, a set of associated default controls has been identified by the project team as being applicable. These default controls, expressed as control codes1, are listed in Table 5.2. 5.17 Additional controls under section 77A are available to manage the risks associated with PROTIM Aquazole Ready-to-use, which are not addressed by the default controls. These are considered in Paragraph 5.23 of this decision. 5.18 As the proposed substance has a reduced hazard profile when compared to the reference substance, many of the controls assigned to the reference substance (F1, F2, F3, F5, F6, F11, F12, F14, F16, T3, T6, T8, E4, I5, I8, I13, I20, I25, I30, P5, D2, EM9 and EM10) are not applicable. As both products have the same use pattern, the remaining controls are the same other than some minor labelling differences and changes to some trigger quantities. 5.19 The project team notes that controls, E2 (Restrictions on use of substances in application areas), E3 (Controls relating to protection of terrestrial invertebrates) and E5 (Requirements for keeping records of use) have been triggered for PROTIM Aquazole Ready-to-use on the basis of its intrinsic hazards. However, these controls were not considered relevant based on the substance’s use as a timber treatment and have therefore not been listed. This is consistent with the reference substance. Table 5.2: List of default controls for PROTIM Aquazole Ready-to-use Toxicity Controls T1 Limiting exposure to toxic substances through the setting of TELs T2 Controlling exposure in places of work through the setting of WESs. T4 Requirements for equipment used to handle substances T5 Requirements for protective clothing and equipment T7 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles Ecotoxicity Controls E1 Limiting exposure to ecotoxic substances through the setting of EELs E6 Requirements for equipment used to handle substances E7 Approved handler/security requirements for certain ecotoxic substances Identification Controls Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A detailed list of these codes is contained in the ERMA New Zealand User Guide to the Controls Regulations. Environmental Risk Management Authority Decision: Application HSR07033 Page 10 of 40 1 I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability I3 Priority identifiers for ecotoxic substances I9 Secondary identifiers for all hazardous substances I11 Secondary identifiers for ecotoxic substances I16 Secondary identifiers for toxic substances I17 Use of generic names I18 Requirements for using concentration ranges I19 Additional information requirements, including situations where substances are in multiple packaging I21 General documentation requirements I23 Specific documentation requirements for ecotoxic substances I28 Specific documentation requirements for toxic substances I29 Signage requirements Packaging Controls P1 General packaging requirements P3 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria P13 Packaging requirements for toxic substances P15 Packaging requirements for ecotoxic substances PG3 Packaging requirements equivalent to UN Packing Group III PS4 Packaging requirements as specified in Schedule 4 Disposal Controls D4 Disposal requirements for toxic substances D5 Disposal requirements for ecotoxic substances D6 Disposal requirements for packages D7 Information requirements for manufacturers, importers and suppliers, and persons in charge D8 Documentation requirements for manufacturers, importers and suppliers, and persons in charge Emergency Management Controls EM1 Level 1 information requirements for suppliers and persons in charge EM6 Information requirements for toxic substances EM7 Information requirements for ecotoxic substances EM8 Level 2 information requirements for suppliers and persons in charge EM11 Level 3 emergency management requirements: duties of person in charge, emergency response plans EM12 Level 3 emergency management requirements: secondary containment EM13 Level 3 emergency management requirements: signage Tracking Controls TR1 General tracking requirements Approved Handler Controls AH1 Approved Handler requirements (including test certificate and qualification requirements) Tank Wagon and Transportable Containers Controls The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers. Setting of exposure limits and application rates 5.20 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 relating to TELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. The project team Environmental Risk Management Authority Decision: Application HSR07033 Page 11 of 40 notes that TELs have not been set for the reference substance and therefore proposes that no TELs should be set at this time for PROTIM Aquazole Ready-to-use. 5.21 Control T2 relates to the requirement to set Workplace Exposure Standards (WESs). Under regulation 29(2) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001, the project team proposes as a workplace exposure standard for component E, the value or values 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. 5.22 Control E1 relates to limiting exposure to ecotoxic substances through the setting of Environmental Exposure Limits (EELs). ERMA New Zealand is considering a range of issues relating to EELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. The project team notes that EELs have not been set for the reference substance and therefore proposes that no EELs should be set at this time for PROTIM Aquazole Ready-to-use and that the default EELwater be deleted. Additional controls under section 77A 5.23 Under section 77A, the Authority may impose as controls any obligations and restrictions that the Authority thinks fit. Before imposing a control under this section, the Authority must be satisfied that, against any other specified controls applying to PROTIM Aquazole Ready-to-use: (a) the proposed control is more effective in terms of its effect on the management, use and risks of hazardous substances; or (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of hazardous substances; or (c) the proposed control is more likely to achieve its purpose. 5.24 The project team considers that the following controls are applicable to PROTIM Aquazole Ready-to-use as discussed below: 5.24.1 The project team notes that the assessment of PROTIM Aquazole Ready-to-use has been based solely upon the substance being used as a timber treatment but none of the default controls limits how the substance may be used. Accordingly, the Agency considers that the following control should be applied to PROTIM Aquazole Ready-to-use as it will be more effective than the specified (default) controls in terms of its effect on the management, use and risks of the substance: PROTIM Aquazole Ready-to-use shall only be used as an agent in the preservation treatment of timber at industrial sites. 5.24.2 The project team notes that the specified controls do not address the risks associated with stationary container systems and they do not allow for dispensation where it is unnecessary for any associated pipework to have secondary containment. Accordingly, the project team considers that the application of controls addressing these risks will be more effective than the specified (default) controls in terms of their effect on the management, use and risks of the substance. Such controls were applied to timber treatments on transfer to the HSNO regime. The project team considers that these controls are similarly appropriate for the management of the risks associated Environmental Risk Management Authority Decision: Application HSR07033 Page 12 of 40 with PROTIM Aquazole Ready-to-use and proposes that the following controls should be applied to the substance: The controls relating to stationary container systems and secondary containment as set out in Schedules 8 and 9 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. 5.24.3 The project team considers that the following subclauses should be added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001 (control EM12): (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. Variation of controls under section 77 5.25 Under section 77, the default controls triggered for the substance may be varied. Under section 77(3), controls may be substituted or added. Under section 77(4), controls may be substituted or deleted. Under section 77(5), where a substance triggers more than one hazard classification, controls may be combined. 5.26 The Agency considers that the following controls should be varied under section 77(4)(b) for PROTIM Aquazole Ready-to-use, as the variations will not significantly increase the adverse effects of the substance: 5.26.1 Control T7 relates to restrictions on the carriage of hazardous substances on passenger service vehicles. The trigger quantity that would normally apply for a substance with the hazard classification of PROTIM Aquazole Ready-to-use is 0.1 L, as driven by the sensitisation classification. However, the project team notes that the trigger quantity for sensitisation was varied for pesticides transferred to the Act under the Hazardous Substances (Pesticides) Transfer Notice 2004, from 0.1 L to I L. Consequently, the Agency considers that the quantity of PROTIM Aquazole Ready-to-use triggering this requirement should likewise be increased to 1 L. 5.26.2 Controls E7, AH1 and TR1 relate to tracking requirements for PROTIM Aquazole Ready-to-use triggered as a result of its 9.1A classification. As this substance will not be used in a wide dispersive manner, the project team consider that the approved handler controls can be deleted as provided by section 77(4)(b). Further, where the tracking controls have been triggered solely as a result of ecotoxicity, it is considered that any risks arising during Environmental Risk Management Authority Decision: Application HSR07033 Page 13 of 40 the substance’s life-cycle are adequately managed by other controls such as packaging, labelling and emergency management requirements. The project team therefore proposes that the tracking controls be deleted as provided by section 77(4)(b). This approach is consistent with the Authority’s policy on approved handler and tracking controls for class 9 substances (November 2003). 5.26.3 Controls I16 and I21 relate to requirements to identify certain toxic components on labels and in accompanying documentation. In accordance with the Hazardous Substances Standing Committee determination of March 2006, the Agency considers that the following components should be specified on the label and documentation for PROTIM Aquazole Ready-to-use: Labelling requirement component C 5.27 Documentation requirement component C The Agency considers that the following controls may be combined under section 77(5) for PROTIM Aquazole Ready-to-use as they relate to the same requirements: 5.27.1 Controls T4 and E6 which relate to requirements for equipment used to handle PROTIM Aquazole Ready-to-use. 5.27.2 Controls P3, P13 and P15 which relate to packaging requirements for PROTIM Aquazole Ready-to-use. 5.27.3 Controls D4 and D5 which relate to disposal requirements for PROTIM Aquazole Ready-to-use. 5.28 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)). 5.29 The modifications to controls, as above, have been incorporated into the list of controls for PROTIM Aquazole Ready-to-use detailed in Appendix 2. 6 Comparison of the adverse effects 6.1 The project team notes that there are no substantial differences in the life-cycle, use, purpose and presentations between the proposed substances and the reference substance. 6.2 Given the similarities in life-cycle and use of PROTIM Aquazole Concentrate, PROTIM Aquazole Ready-to-use and the reference substance, the project team does not expect that an increase in potential exposure will occur. As the risks posed by the proposed substances are somewhat less than that of the reference substance, the project team considers that the controls assigned to the reference substance, with the exceptions as described in Paragraph 5.4 for PROTIM Aquazole Concentrate and Paragraph 5.18 for PROTIM Aquazole Ready-to-use, are similarly applicable. 6.3 The project team considers that there are no other matters which would prevent this application for PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use from being rapidly assessed. Environmental Risk Management Authority Decision: Application HSR07033 Page 14 of 40 7 Environmental user charges 7.1 The project team considers that use of controls on PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use is an effective means of managing risks associated with these substances. At this time, no consideration has been given to whether or not environmental charges should be applied to these substances as an alternative or additional means of achieving effective risk management. Accordingly, no report has been made to the Minister for the Environment. 8 Decision 8.1 Pursuant to section 28A, I have considered this application to import or manufacture hazardous substances for release made under section 28. 8.2 Having considered the compositions, hazardous properties, and uses for PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use, I am satisfied that the proposed substances meet the criteria for rapid assessment under section 28A(2)(c) in that they have been formulated so that one or more of their hazardous properties have a lesser degree of hazard than an approved reference substance. 8.3 As the risks posed by the proposed substances are somewhat less than that of the reference substance, I consider that applying the same suite of controls to PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use will ensure adequate management of any adverse effects, with the exceptions as described in Paragraphs 5.4 and 5.18, the setting of exposure limits and application rates proposed under Paragraphs 5.6 to 5.8 and 5.20 to 5.22 (inclusive), the additions proposed under Paragraphs 5.10 to 5.10.3 and 5.23 to 5.24.3 (inclusive) and the amendments proposed under Paragraphs 5.11 to 5.13.3 and 5.25 to 5.27.3 (inclusive). 8.4 In this consideration, I have also applied the following criteria in the Methodology: clause 9 – equivalent of sections 5, 6 and 8; clause 12 – risk assessment; clause 21 – the decision accords with the requirements of the Act and regulations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; clause 25 – the evaluation of risks; and clause 35 – the costs and benefits of varying the default controls. 8.5 The application for importation and manufacture of the hazardous substances, PROTIM Aquazole Concentrate and PROTIM Aquazole Ready-to-use for release is thus approved with controls as detailed in Appendix 1 and Appendix 2. Johanne Spring Date: 16 April 2007 Acting Chief Executive, ERMA New Zealand PROTIM Aquazole Concentrate ERMA New Zealand Approval Code: HSR007777 PROTIM Aquazole Ready-to-use ERMA New Zealand Approval Code: HSR007778 Environmental Risk Management Authority Decision: Application HSR07033 Page 15 of 40 Appendix 1: controls applying to PROTIM Aquazole Concentrate The controls imposed on PROTIM Aquazole Concentrate 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 Regulation2 Explanation3 Code1 Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property Controls F2 8 General public transportation restrictions and requirements for PROTIM Aquazole Concentrate T7 10 The maximum quantity per package of PROTIM Aquazole Concentrate to be Classes 6,8 and 9 carried on passenger service vehicles is 1 L. control regulations F6 F11 60-70 76 Requirements to reduce the likelihood of unintended ignition of PROTIM Aquazole Concentrate These regulations prescribe controls to reduce the likelihood of unintended ignition of PROTIM Aquazole Concentrate. 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 PROTIM Aquazole Concentrate under any of regulations 63(4), 65, 67 and 69 must be an approved handler for that substance, ie the trigger quantities that typically activate approved handler requirements do not apply [Regulation 60(2)]. Segregation of incompatible substances In order to reduce the likelihood of unintended ignition of PROTIM Aquazole Concentrate, there is a requirement to ensure that it does not come into contact with any incompatible substance as below. There is also a requirement that packages of incompatible substances are held separately: all class 1 substances all class 2 substances 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. 1 Environmental Risk Management Authority Decision: Application HSR07033 Page 16 of 40 class 3.2 substances all class 4 substances all class 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. 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). No ADE or TEL values are set for PROTIM Aquazole Concentrate at this time. T2 29, 30 Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of 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. OSH WES values have been adopted for component E in PROTIM Aquazole Concentrate. T4, E6 7 Requirements for equipment used to handle hazardous substances Any equipment used to handle PROTIM Aquazole Concentrate must retain and/or dispense the substance in the manner intended, ie without leakage, and must be accompanied by sufficient information so that this can be achieved. T5 8 Requirements for protective clothing and equipment Protective clothing/equipment must be employed when PROTIM Aquazole Concentrate is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with the substance and is not directly exposed to a concentration of the substances that is greater than the WES for that substance. The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing/equipment may be used, and the requirements for maintaining the clothing/equipment. Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 Limiting exposure to ecotoxic substances This control relates to the setting of environmental exposure limits (EELs). No EELs have been set for PROTIM Aquazole Concentrate at this time and default water EEL is deleted. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of PROTIM Aquazole Concentrate in terms of: information that must be “immediately available” with PROTIM Aquazole Concentrate (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 PROTIM Aquazole Concentrate. I1 6, 7, 32-35, General identification requirements 36 (1)-(7) These controls relate to the duties of suppliers and persons in charge of PROTIM Aquazole Concentrate with respect to identification (essentially labelling) (Regulations 6 and 7), accessibility of the required information Environmental Risk Management Authority Decision: Application HSR07033 Page 17 of 40 (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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate (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 PROTIM Aquazole Concentrate 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 it 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 PROTIM Aquazole Concentrate (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. I3 9 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 ie 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 PROTIM Aquazole Concentrate must be prominently identified as being ecotoxic. This information must be available to any person handling PROTIM Aquazole Concentrate within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Environmental Risk Management Authority Decision: Application HSR07033 Page 18 of 40 I5 I8 11 14 I9 18 I11 20 I13 22 Priority identifiers for flammable substances This requirement specifies that PROTIM Aquazole Concentrate must be prominently identified as being flammable. In addition, the following information must be provided: an indication that PROTIM Aquazole Concentrate is a liquid; information must be provided on its general degree of hazard (ie flammable liquids: low hazard). 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 PROTIM Aquazole Concentrate must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of PROTIM Aquazole Concentrate and the need to restrict access to the substance by children. This information must be available to any person handling PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 ecotoxic substances This control relates to the additional label detail required for PROTIM Aquazole Concentrate. 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 (ie very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates). Secondary identifiers for flammable substances This control relates to the additional label detail required for PROTIM Aquazole Concentrate. 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 (ie flammable liquids: low hazard); 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. Environmental Risk Management Authority Decision: Application HSR07033 Page 19 of 40 I16 25 I17 26 Secondary identifiers for toxic substances This control relates to the additional label detail required for PROTIM Aquazole Concentrate. 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, respiratory sensitiser, 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 component C. 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 Regulation 25(e). 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 [Regulation 25 (e) specifies a requirement to list on the product label, the name of component C]. 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 Regulation 25(e). [Regulation 25 (e) specifies a requirement to list on the product label, the name of component C]. 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 PROTIM Aquazole Concentrate is contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance (ie flammable liquids: low hazard, acutely toxic, irritating to the skin, irritating to the eye, respiratory sensitiser, contact sensitiser, harmful to human target organs or systems, very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates). Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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, ie the Environmental Risk Management Authority Decision: Application HSR07033 Page 20 of 40 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate equal to or greater than 1 L, if it is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where hazardous substances are present in quantities equal to or greater than those specified in Regulation 38 (and with reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation required for each hazardous substance concerned. The person in charge must also ensure that the documentation does not contain any information that suggests that the substance belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate’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 PROTIM Aquazole Concentrate that, when in a closed container, is likely to become more hazardous over time or develop Environmental Risk Management Authority Decision: Application HSR07033 Page 21 of 40 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 PROTIM Aquazole Concentrate; the date on which the documentation was prepared; the name, concentration and CAS number of components A, B and C. 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 PROTIM Aquazole Concentrate 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 the substance is being transported. I23 41 I25 43 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 PROTIM Aquazole Concentrate must include the following information: its general degree and type of ecotoxic hazard (ie very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates); 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 PROTIM Aquazole Concentrate must include the following information: its general degree and type of hazard (ie flammable liquids: low 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; Environmental Risk Management Authority Decision: Application HSR07033 Page 22 of 40 I28 46 I29 51-52 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 PROTIM Aquazole Concentrate must include the following information: its general degree and type of toxic hazard (ie acutely toxic, irritating to the skin, irritating to the eye, respiratory sensitiser, 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 PROTIM Aquazole Concentrate 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 (ie flammable liquids: low hazard, very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance. I30 53 Advertising PROTIM Aquazole Concentrate Any advertisement for PROTIM Aquazole Concentrate must include information that identifies the substance is toxic and indicates the need to restrict access by children. In addition, it must specify the general degree and type of hazard (unless it 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 PROTIM Aquazole Concentrate with any previous contents of the packaging. Environmental Risk Management Authority Decision: Application HSR07033 Page 23 of 40 Regulation 5 – Ability to retain contents Packaging for PROTIM Aquazole Concentrate 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 reclosed. The packaging in direct contact with PROTIM Aquazole Concentrate must not be significantly affected or weakened by contact with it such that the foregoing requirements cannot be met. Regulation 6 – Packaging markings Packages containing PROTIM Aquazole Concentrate must not be marked in accordance with the UN Model Regulations unless: the markings comply with the relevant provisions of that document; and the packaging complies with the tests set out in Schedule 3 (Packaging Regulations); and the design of the packaging has been test certified as complying with those tests. Regulation 7(1) – Requirements when packing hazardous substance When packing PROTIM Aquazole Concentrate, 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 PROTIM Aquazole Concentrate must not be packed in packaging that has been previously used for 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate PROTIM Aquazole Concentrate in quantities over 1 L must be packaged according to Schedule 3 (UN PGIII), but must be packaged according to Schedule 3 or Schedule 4 when in quantities equal to or less than 1 L PROTIM Aquazole Concentrate that is offered for sale in a package of less than 2.5 L must be in child resistant packaging (ie 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 PROTIM Aquazole Concentrate when packaged in quantities of more than 1 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 PROTIM Aquazole Concentrate when packaged in quantities equal to or less than 1 L. Environmental Risk Management Authority Decision: Application HSR07033 Page 24 of 40 Hazardous Substances (Disposal) Regulations 2001 D2, D4, 6, 8, 9 Disposal requirements for PROTIM Aquazole Concentrate D5 As provided by section 77(5), the disposal requirements for PROTIM Aquazole Concentrate have been combined. These substances must be disposed of by: treating the substance so that it is no longer a hazardous substance; exporting the substance from New Zealand as a hazardous waste; treatment can include controlled burning providing the performance requirements as set out in regulation 6 (3)(b) of the Disposal Regulations for protecting people and the environment are met, and the burning operation does not exceed any TELs or EELs; treatment includes discharge into the environment as waste, or depositing in a landfill, provided the discharge location is managed so that: - the substance will not at any time come into contact with any substances with explosive or oxidising properties, and - 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 the substance 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 PROTIM Aquazole Concentrate 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 any quantity of PROTIM Aquazole Concentrate. 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 ie that would not comply with the Disposal Regulations. Such information must be accessible to a person handling PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 Environmental Risk Management Authority Decision: Application HSR07033 Page 25 of 40 (essentially on the label) that must be provided with PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate is being transported. Information requirements for toxic substances The following information must be provided when PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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, ie 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 PROTIM Aquazole Concentrate There is an additional requirement for PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate is held in a place of work in quantities exceeding 500 L must have two fire extinguishers. The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching PROTIM Aquazole Concentrate, rather than providing sufficient capacity to extinguish Environmental Risk Management Authority Decision: Application HSR07033 Page 26 of 40 any possible fire involving large quantities of hazardous substances. EM11 EM12 25-34 35-41 Each fire extinguisher must be located within 30 m of PROTIM Aquazole Concentrate 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 (50 mm deep and at least 6 m2 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 PROTIM Aquazole Concentrate 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 PROTIM Aquazole Concentrate 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, eg there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained. The following subclauses shall be added after subclause (3) of regulation 36: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. Environmental Risk Management Authority Decision: Application HSR07033 Page 27 of 40 EM13 42 Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where PROTIM Aquazole Concentrate is held at quantities equal to or greater than 100 L. Note the quantity specified does not take into account aggregate quantity requirements. 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 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 set under s77A PROTIM Aquazole Concentrate shall only be used as an agent in the preservation treatment of timber at industrial sites. 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, shall apply to this substance, notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10. EM12: refer to EM12 for explanation of additional subclauses. Environmental Risk Management Authority Decision: Application HSR07033 Page 28 of 40 Appendix 2: controls applying to PROTIM Aquazole Ready-to-use The controls imposed on PROTIM Aquazole Ready-to-use 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 Regulation2 Explanation3 Code1 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). No ADE or TEL values are set for PROTIM Aquazole Ready-to-use at this time. T2 29, 30 Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of 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. OSH WES values have been adopted for component E in PROTIM Aquazole Ready-to-use. T4, E6 7 Requirements for equipment used to handle hazardous substances Any equipment used to handle PROTIM Aquazole Ready-to-use must retain and/or dispense the substance in the manner intended, ie without leakage, and must be accompanied by sufficient information so that this can be achieved. T5 8 Requirements for protective clothing and equipment Protective clothing/equipment must be employed when PROTIM Aquazole Ready-to-use is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with the substance and is not directly exposed to a concentration of the substances that is greater than the WES for that substance. The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing/equipment may be used, and the requirements for maintaining the clothing/equipment. T7 10 Restrictions on the carriage of hazardous substances on passenger service vehicles In order to limit the potential for public exposure to PROTIM Aquazole Ready-to-use, the maximum quantity per package 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). No EELs have been set for PROTIM Aquazole Ready-to-use at this time and default water EEL is deleted. 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. 1 Environmental Risk Management Authority Decision: Application HSR07033 Page 29 of 40 Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of PROTIM Aquazole Ready-to-use in terms of: information that must be “immediately available” with PROTIM Aquazole Ready-to-use (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 PROTIM Aquazole Ready-to-use. I1 6, 7, 32-35, General identification requirements 36 (1)-(7) These controls relate to the duties of suppliers and persons in charge of PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use (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 PROTIM Aquazole Ready-to-use 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 it 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 PROTIM Aquazole Ready-to-use (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 Environmental Risk Management Authority Decision: Application HSR07033 Page 30 of 40 I3 9 I9 18 I11 20 I16 25 I17 26 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 ie 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 PROTIM Aquazole Ready-to-use must be prominently identified as being ecotoxic. This information must be available to any person handling PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 ecotoxic substances This control relates to the additional label detail required for PROTIM Aquazole Ready-to-use. 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 (ie very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates). Secondary identifiers for toxic substances This control relates to the additional label detail required for PROTIM Aquazole Ready-to-use. 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 irritating to the skin, irritating to the eye, respiratory sensitiser, contact sensitiser); 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 component C. 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 Regulation 25(e). Environmental Risk Management Authority Decision: Application HSR07033 Page 31 of 40 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 [Regulation 25(e) specifies a requirement to list on the product label, the name of component C]. 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 Regulation 25(e). [Regulation 25 (e) specifies a requirement to list on the product label, the name of component C]. 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 PROTIM Aquazole Ready-to-use is contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance (ie irritating to the skin, irritating to the eye, respiratory sensitiser, contact sensitiser, very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates). Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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, ie the hazardous properties of the substance must be identified; or be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant; or in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background); or bear the relevant class 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 PROTIM Aquazole Ready-to-use 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 Environmental Risk Management Authority Decision: Application HSR07033 Page 32 of 40 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use equal to or greater than 1 L, if it is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where hazardous substances are present in quantities equal to or greater than those specified in Regulation 38 (and with reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation required for each hazardous substance concerned. The person in charge must also ensure that the documentation does not contain any information that suggests that the substance belongs to a class or subclass it does not in fact belong to. Regulation 39 – General content requirements for documentation The documentation provided with PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use’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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use; the date on which the documentation was prepared; the name, concentration and CAS number of component C. 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 PROTIM Environmental Risk Management Authority Decision: Application HSR07033 Page 33 of 40 Aquazole Ready-to-use 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 the substance is being transported. I23 41 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 ecotoxic substances The documentation provided with PROTIM Aquazole Ready-to-use must include the following information: its general degree and type of ecotoxic hazard (ie very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates); 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 PROTIM Aquazole Ready-to-use must include the following information: its general degree and type of toxic hazard (ie irritating to the skin, irritating to the eye, respiratory sensitiser, contact sensitiser); 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 PROTIM Aquazole Ready-to-use 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; Environmental Risk Management Authority Decision: Application HSR07033 Page 34 of 40 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 (very ecotoxic in the aquatic environment, ecotoxic to terrestrial invertebrates); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance. 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 PROTIM Aquazole Ready-to-use with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for PROTIM Aquazole Ready-to-use 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 reclosed. The packaging in direct contact with PROTIM Aquazole Ready-to-use must not be significantly affected or weakened by contact with it such that the foregoing requirements cannot be met. Regulation 6 – Packaging markings Packages containing PROTIM Aquazole Ready-to-use must not be marked in accordance with the UN Model Regulations unless: the markings comply with the relevant provisions of that document; and the packaging complies with the tests set out in Schedule 3 (Packaging Regulations); and the design of the packaging has been test certified as complying with those tests. Regulation 7(1) – Requirements when packing hazardous substance When packing PROTIM Aquazole Ready-to-use, 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 PROTIM Aquazole Ready-to-use must not be packed in packaging that has been previously used for 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 PROTIM Aquazole Ready-to-use in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004; or a stationary container system, a stationary tank or a tank (as defined in the Environmental Risk Management Authority Decision: Application HSR07033 Page 35 of 40 P3, P13, P15 9, 19, 21 Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for PROTIM Aquazole Ready-to-use PROTIM Aquazole Ready-to-use in quantities over 1 L must be packaged according to Schedule 3 (UN PGIII), but must be packaged according to Schedule 3 or Schedule 4 when in quantities equal to or less than 1 L. PROTIM Aquazole Ready-to-use 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. PG3 Schedule 3 This schedule describes the (minimum) packaging requirements that must be complied with for PROTIM Aquazole Ready-to-use when packaged in quantities of more than 1 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 PROTIM Aquazole Ready-to-use when packaged in quantities equal to or less than 1 L. Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for PROTIM Aquazole Ready-to-use PROTIM Aquazole Ready-to-use must be disposed of by: treating it so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not include dilution of PROTIM Aquazole Ready-to-use with any other substance prior to discharge to the environment; or discharging it to the environment provided that after reasonable mixing, the concentration of PROTIM Aquazole Ready-to-use in any part of the environment outside the mixing zone does not exceed any TELs (tolerable exposure limits) or any EELs (environmental exposure limits) set by the Authority; or exporting it from New Zealand as a hazardous waste. D6 10 Disposal requirements for packages This control gives the disposal requirements for packages that contained PROTIM Aquazole Ready-to-use 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 any quantity of PROTIM Aquazole Ready-to-use. 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 ie that would not comply with the Disposal Regulations. Such information must be accessible to a person handling PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use that exceeds 1 L. The documentation must describe one or more methods of disposal (that Environmental Risk Management Authority Decision: Application HSR07033 Page 36 of 40 comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use is being transported. Information requirements for toxic substances The following information must be provided when PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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 PROTIM Aquazole Ready-to-use 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, ie 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 Environmental Risk Management Authority Decision: Application HSR07033 Page 37 of 40 These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where PROTIM Aquazole Ready-to-use is held (or reasonably likely to be held on occasion) 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 PROTIM Aquazole Ready-to-use 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, eg there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained. The following subclauses shall be added after subclause (3) of regulation 36: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (5) In this clause, pipework— (a) means piping that— (i) is connected to a stationary container; and (ii) is used to transfer a hazardous substance into or out of the stationary container; and (b) includes a process pipeline or a transfer line. EM13 42 Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where PROTIM Aquazole Ready-to-use is held at quantities equal to or greater than 100 L. Note the quantity specified does not take into account aggregate quantity requirements. 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 Environmental Risk Management Authority Decision: Application HSR07033 Page 38 of 40 Regulations 4 to 43 where applicable The Hazardous Substances (Tank Wagons and Transportable 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 PROTIM Aquazole Ready-to-use shall only be used as an agent in the preservation treatment of timber at industrial sites. The controls relating to stationary container systems and secondary containment as set out in Schedules 8 and 9 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. EM12: refer to EM12 for explanation of additional subclauses. Environmental Risk Management Authority Decision: Application HSR07033 Page 39 of 40 Appendix 3: Confidential Information Environmental Risk Management Authority Decision: Application HSR07033 Page 40 of 40