HSR02037 - decision document - EPA



ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

14 November 2002

|Application code |HSR02043 |

|Application type |To import or manufacture any hazardous substance under Section 28A(2)(b) of the Hazardous |

| |Substances and New Organisms (HSNO) Act 1996 |

|Applicant |AGRENZ Limited |

|Purpose |To import AQUABAC xt, a biological larvicide, formulated as an aqueous suspension containing |

| |Bacillus thuringiensis var. israelensis (Bti), for the control of mosquito larvae. |

|Date received |31 October 2002 |

|Consideration date |14 November 2002 |

|Considered by |Bas Walker (Chief Executive, ERMA New Zealand) |

1. Summary of Decision

1. The application to import AQUABAC xt is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998.

2. The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register:

AQUABAC xt

3. ERMA New Zealand has adopted the use classification system as the basis for recording the nature and uses of substances approved. The following use categories are recorded for this substance:

|Main Category: |4 |Wide dispersive use |

|Industrial category: |6 |Public domain |

|Function/Use category: |39 |Pesticides, non-agricultural |

2. Legislative Criteria for Application

1. The application was lodged pursuant to section 28 of the HSNO Act. The decision was determined in accordance with section 28A(2)(b), taking into account matters relevant to the purpose of the Act, as specified under Part II of the HSNO Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the HSNO Act.

2. Consideration of the application followed the relevant provisions of the Hazardous Substances and New Organisms (Methodology) Order 1998 (the Methodology). Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology.

3. In accordance with section 28A(2)(b) and clause 24, the approach adopted when considering this application was to determine whether the substance had one or more hazardous properties and if each of those hazardous properties met the criteria for least degree of hazard for that property. Then, having regard to the default controls triggered by the classification, potentially significant risks were identified to determine whether they provided any reason why this substance should not be approved by rapid assessment. Finally, the default controls were reviewed to address their application to this substance (clause 35), and to address any residual risks.

3. Application Process

1. The purpose of the application is to import AQUABAC xt which is intended for use for the control of mosquito larvae.

2. The application was received from AGRENZ Ltd on 31 October 2002. It was verified as having sufficient information on 5 November 2002.

3. The applicant supplied the following documents that included information identified as confidential:

• Application HSR02043

• Application Appendix A (confidential information) containing information on the composition, label and material safety data sheets

• Application Appendix B, Report for the Ministry of Health “Environmental and health impacts of Bacillus thuringiensis israelensis”

4. The ACVM Group of the New Zealand Food Safety Authority (NZFSA), the Department of Conservation, the Ministry of Health and the Department of Labour (Occupation Health and Safety) were advised of the application. No comments were received.

5. The applicant has noted that AQUABAC xt is not subject to ACVM approval as it is not being used in agriculture or on food crops.

6. The ERMA New Zealand Senior Advisor on Māori issues was advised of the application. His comments are included in paragraph 8.6 of this Decision.

Current use of Bti products in New Zealand

7. Bti products have been widely supported by health authorities, such as WHO, as they have demonstrated effectiveness against disease vectors with few deleterious effects on non-target organisms or the environment (Clarke 1994). In New Zealand there are a number of Bti products available for pest control of tomato fruitworm, diamond back moth, leafrollers, cabbage white caterpillar, white spotted tussock moth, painted apple moth and one liquid formulation for the control of mosquito larvae (Vectobac 12 AS).

4. AQUABAC xt identification and use

1. AQUABAC xt is a biological larvicide, formulated as an aqueous suspension containing Bacillus thuringiensis var. israelensis (Bti), for the control of mosquito larvae. AQUABAC xt comprises:

|Component name |CAS number |w/w |

|Bacillus thuringiensis var israelensis|68038-71-1 |Confidential (Refer to Appendix A of |

|powder [Bti] | |the application) |

| | | |

|Serotype H-14 | | |

|Non-active ingredients |Confidential (Refer to Appendix A of the |Confidential (Refer to Appendix A of |

| |application) |the application) |

2. AQUABAC xt is intended for public health use for the control of mosquitoes in such areas as fresh and salt water marshes, tidal inlets, polluted water (including sewage lagoons) and storm water retention areas. The substance is designed for application through hydraulic spray equipment, either from aircraft or from the ground.

3. AQUABAC xt is not considered to be a new organism as defined in the HSNO Act, as the active ingredient, although being a bacterium, is not capable of reproducing.

Identification/ characterisation

4. Bacillus thuringiensis (Bt) occurs naturally in New Zealand, particularly in soil and insects. It exists in the environment as spores which have little or no metabolic processes and can survive periods of low nutrition and desiccation.

5. Agrenz Ltd intends to import up to 6,000 litres of the substance at any one time by sea to Auckland in 30 US Gallon (113.5 L) HDPE drums. The applicant notes that as long as the product is kept in a cool and dry place, AQUABAC xt will retain its activity for at least three years.

Host range

6. Bti insecticidal activity is restricted in host range to the subclass Nematocera. Bti is highly pathogenic against Culicidae (mosquitoes) and Simuliidae (blackflies) and has some virulence against other Diptera, especially Chironomidae (midges). Table 2 in the report for the Ministry of Health details the hosts susceptible to Bti.

7. It could be well expected that non-target mortality could be expected in these families. Among New Zealand’s 14 known Culicidae listed in Table 5, Ministry of Health Report, 3 genera, Aedes, Culiseta and Culex would be expected to be susceptible. (Note that all New Zealand mosquitoes previously classified as genus Aedes have now been reclassified as genus Ochlerotatus). Three of these native mosquitoes Ochlerotatus chathamicus, Culex rotoruae and Culiseta novaezealandiae are endemic to Chatham Islands, Rotorua and south east Otago respectively. The other native mosquitoes are widely distributed throughout New Zealand.

8. While some or most species of Simuliidae and Chironomidae would be susceptible, effects would only occur at the area of application, as Bti does not recycle readily in populations.

Mode of action

9. AQUABAC xt contains the spores and parasporal crystals of Bti H-14 serotype. Following ingestion, the parasporal crystals become soluble in the alkaline larval midgut, followed by proteolytic activation of the soluble insecticidal crystal proteins. The toxin binds to a receptor on the midgut cell wall resulting in pore formation in the cell, which leads to death of the larvae. Treated mosquito larvae generally cease feeding within 1 hour, show reduced activity by two hours, extreme sluggishness by four hours and general paralysis by six hours after ingestion.

Use of the substance

10. The level of Bti released into the environment is controlled by the application rate specified in the directions on the label. On exposure to the atmosphere, Bti is rapidly degraded (24-36 hours) to non-toxic end products by UV light and by the action of soil microflora. No toxic by-products will be created.

5. Hazard Classification

1. The applicant states that AQUABAC xt has a 9.1D hazard profile because of the biocidal nature of the substance (ie it kills mosquito larvae).

2. The applicant has relied upon the Ministry of Health report which provides information on effects to non target organisms such as, fish, acari, amphibians, crustaceans, insects, flatworms, earthworms, nematode, molluscs, mice, rats and rabbits.

3. I have assessed the information from the applicant and consider the following hazard profile for AQUABAC xt applies:

|Class |Characteristic |Triggered/Not triggered |

|Class 1: |Explosiveness |Not triggered |

|Class 2-4: |Flammability |Not triggered |

|Class 5: |Oxidising Properties |Not triggered |

|Class 6 |Toxic |Not triggered |

|Class 8: |Corrosiveness |Not triggered |

|Class 9: |Ecotoxic |Triggered |

4. I agree with the applicant that AQUABAC xt triggers the 9.1D classification based on the substance being designed as a biocide and not classified in a higher category. This classification is conditional on the substance having no other ecotoxic property effects.

5. Bti is a biopesticide and as such its activity is not measured in the normal ecotoxicological units of LC50 (mg/L), rather in measures such as “spores per L”. It is not persistent in the aquatic environment (though it is a naturally occurring bacterium).

6. I note that while one of the confidential components is a sensitiser, it does not trigger the sensitisation hazardous property threshold at the very low levels at which it is included in the formulation.

6. Evaluation Against the Criteria for Least Degree of Hazard

1. The classification category of 9.1D meets the requirements of the least degree of hazard criteria. This is the lowest hazard category of subclass 9.1 and is one of the categories accepted by the Authority as appropriate for consideration by the rapid assessment route.

2. I consider AQUABAC xt is eligible for rapid assessment under section 28A(2)(b).

7. Default Controls

1. The default controls[1] associated with classification 9.1D are listed below (referenced to excerpts from the Controls Matrix – see ERMA New Zealand User Guide to HSNO Control Regulations)

Default controls for AQUABAC xt

|Ecotoxic Substances |Classes (6, 8 and 9) Controls |Description |

| |Regulations | |

|E1 |Regulations 32-45 |Limiting exposure to ecotoxic substances, the environmental exposure limit|

| | |(EEL) approach |

|E2 |Regulations 46-48 |Restrictions on use of substances in application areas |

|E6 |Regulation 7 |Requirements for equipment used to handle substances |

|E8 |Regulation 10 |Restrictions on carriage of ecotoxic substances on passenger service |

| | |vehicles |

|Identification |Identification Regulations |Description |

|I1 |Regulations 6, 7, 32-35, 36 (1)-(7) |Identification requirements, duties of persons in charge, accessibility, |

| | |comprehensibility, clarity and durability |

|I9 |Regulation 18 |Secondary identifiers for all hazardous substances |

|I11 |Regulation 20 |Secondary identifiers for ecotoxic substances |

|I19 |Regulation 29-31 |Additional information requirements, including situations where substances|

| | |are in multiple packaging |

|I21 |Regulations 37-39, 47-50 |General documentation requirements |

|I29 |Regulations 51, 52 |Signage requirements |

|Packaging |Packaging Regulations |Description |

|P1 |Regulations 5, 6, 7 (1), 8 |General packaging requirements |

|P3 |Regulation 9 |Criteria that allow substances to be packaged to a standard not meeting |

| | |Packing Group I, II or III criteria |

|Disposal |Disposal Regulations |Description |

|D5 |Regulation 9 |Disposal requirements for class 9 substances (ecotoxic) |

|D6 |Regulation 10 |Disposal requirements for packages |

|D7 |Regulations 11, 12 |Information requirements for manufacturers, importers and suppliers, and |

| | |persons in charge |

|D8 |Regulations 13, 14 |Documentation requirements for manufacturers, importers and suppliers, and|

| | |persons in charge |

|Emergency Management |Emergency Management Regulations |Description |

|EM1 |Regulations 6, 7, 9-11 |Level 1 information requirements for suppliers and persons in charge |

|EM7 |Regulation 8 (f) |Information requirements for ecotoxic substances |

|EM8 |Regulations 12-16, 18-20 |Level 2 information requirements for suppliers and persons in charge |

|EM11 |Regulations 25-34 |Level 3 emergency management requirements: duties of person in charge, |

| | |emergency response plans |

|EM12 |Regulations 35-41 |Level 3 emergency management requirements: secondary containment |

|EM13 |Regulation 42 |Level 3 emergency management requirements: signage |

8. Identification and Assessment of the Significant Risks and Costs

1. I have considered that the information provided by the applicant is relevant and appropriate to the scale and significance of the risks, costs, and benefits associated with the application (as required by clause 8 of the Methodology).

2. In considering the risks associated with AQUABAC xt that may arise from its ecotoxicity classification (9.1D), I have considered the risks to the environment, human health, and Māori.

Environmental/ Māori/ and Human Health effects

3. The substance is not significantly ecotoxic in the aquatic environment to non-target organisms. Direct exposure to the substance is very unlikely to kill fish and aquatic algae, and in this respect the effects on individual organisms are likely to be very minor. The only organisms this substance effects will be target insects in the subclass Nematocera. Bti is highly pathogenic against Culicidae (mosquitoes) and Simuliidae (blackflies) and has some virulence against other Diptera, especially Chironomidae (midges). Due to its relatively narrow target range, it is unlikely to have indirect effects on organisms that feed on aquatic insects.

4. The use of AQUABAC xt in the Chatham Islands, and the Rotorua and South East Otago regions to eradicate invasive mosquitoes could potentially lead to unacceptable effects on the native mosquitoes that are endemic (that is found only) in those regions. This risk may be managed by identifying the respective ranges of the invasive and native species and using the substance in a way that minimizes or avoids adverse effects on the native mosquitoes.

5. Bti has been used for many years in agriculture and forestry situations with no reported problems to human health.

6. I consider that the substance is unlikely to have an impact on the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga. This is on the condition that the substance is used, and that any unwanted and/or excess materials are disposed of in accordance with the controls assigned by this approval.

9. Discussion on Controls

Setting of EEL (Control Code E1)

1. This default control requires that an EEL (Environmental Exposure Limit) is established. This can either be the default value, Regulation 32, or one set in accordance with Regulations 33 to 43 of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001.

2. Regulation 33 allows for the setting of EEL values different from the default values. EELs may be set for one or more environmental media.

3. However, Bti is a natural bacterium in the environment. It is also specific to its range of target organisms and when released from the formulated matrix is rapidly degraded in the aquatic environment.

4. Therefore, I consider the adverse effects of this substance to be less than normal for this classification and I consider this control can be deleted under s.77(4)(a) of the Act.

Setting of Application Rate (Control Code E2)

5. This control requires that an application rate be set if an EEL is set. Regulation 48(2)(a) of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 allows the application rate to be set at the rate specified by the applicant in the application. As an EEL has not been set for this substance then this control is not applicable.

Identification Controls (Control code I11)

6. In order to control the use of AQUABAC xt in areas which may include native mosquitoes endemic to a region, I consider that control I11 should be added to under section 77(3)(a), as the adverse effects identified for AQUABAC xt in these particular circumstances are greater than the adverse effects which would usually be associated with substances given the 9.1D classification.

7. The following text or words of similar meaning should be added to the requirements of Regulation 20 of the Hazardous Substances (Identification) Regulations 2001

“When used in any region where species of native mosquitoes are only found in that region, application should occur in such a way that populations of those native mosquitoes will not be adversely affected.”

Emergency Management Regulations (Control codes EM1 and EM7)

8. I note that Regulations 6, 7 and 8(f) of the Emergency Management Regulations apply to ecotoxic substances and make reference to Schedule 1 of the Emergency Management Regulations. However, there is no reference in Schedule 1 to ecotoxic substances. This omission is due to an error in printing of the Regulations and Schedule 1 was intended to apply to ecotoxic substances in category 9.1D.

9. Accordingly, it is strongly recommended that the applicant provide the appropriate emergency management information on the label.

Controls applying to AQUABAC xt

10. The controls have been reviewed and customised to apply to AQUABAC xt. A full list of the controls that I consider apply to AQUABAC xt is included as Appendix 1.

The use of AQUABAC xt in mass aerial spraying

11. The hazard profile presented by this substance is similar to, and certainly no greater than, substances already in use in New Zealand for similar purposes. Accordingly there is no reason to think that the use of AQUABAC xt poses risks, when used en masse for aerial spraying, which are different from those posed by similar sprays which are already in such use.

12. It is noted that these substances are suitable, and are used in New Zealand, for large scale application for control of pests. Although it is not in the scope of the HSNO Act to set specific controls to cover these situations, care should be exercised to ensure that unnecessary exposure to people is minimised, and that people likely to be exposed are fully informed of the circumstances, and in a position to take action on their own account.

10. Decision

1. In accordance with section 28A(2)(b) of the HSNO Act, and clause 24 of the Methodology the approach adopted when considering this application was to evaluate the substance to determine whether the substance had one or more hazardous properties and if each of those hazardous properties met the criteria for least degree of hazard for that property. Then, having regard to the default controls triggered by the classification, potentially significant residual risks and associated costs were identified for assessment in accordance with clauses 12, 13, 33 and 34. Finally, the default controls were reviewed to address their application to this substance (clause 35), and to address any residual risks.

2. Having considered the risks associated with the lifecycle of AQUABAC xt, I am satisfied that the residual risks or costs associated with this substance, taking account of the controls, are sufficiently low to be acceptable (clause 12).

3. Having considered its hazardous properties I am satisfied that AQUABAC xt meets the criteria for least degree of hazard for each hazardous property, and meets the criteria for rapid assessment under section 28A(2)(b) of the HSNO Act.

4. In accordance with clause 36(2)(b) of the Methodology, I have relied, in particular on section 28A(2)(b) of the Act and also applied the following criteria in the Methodology:

• clause 9 - equivalent of sections 5, 6 and 8;

• clause 12 – evaluation of assessment of risks;

• clause 21 – the decision accords with the requirements of the Act and regulations;

• clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques;

• clause 25 – the evaluation of risks.

• clause 33 – risk characteristics; and

• clause 35 – the costs and benefits of varying the default controls.

5. I am satisfied that the controls imposed, as listed in Appendix 1, will be adequate to manage the adverse effects of AQUABAC xt. Furthermore, it would be prudent (and is recommended) that controls relating to emergency management (Regulation 8) are voluntarily adopted.

6. The application is accordingly approved pursuant to section 28A(2)(b) of the Act with controls as listed in Appendix 1.

|Dr Bas Walker | |Date |

|Chief Executive, ERMA New Zealand | | |

Appendix 1

The controls imposed on AQUABAC xt are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New Zealand publication “User Guide to HSNO Control Regulations” provides useful guidance on the controls.

|Control |Regulation[3] |Explanation[4] |

|Code[2] | | |

|Hazardous Substances Classes (6, 8, and 9) control regulations |

|E6 |Regulation 7 |Requirements for equipment used to handle substances |

| | |Any equipment used to handle ecotoxic substances 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. |

|E8 |Regulation 10 |Restrictions on the carriage of hazardous substances on passenger service vehicles |

| | |In order to limit the potential for environmental exposure to ecotoxic substances, the carriage of AQUABAC xt on public transport vehicles is restricted to 5L per package. |

|Hazardous Substances (Identification) Regulations 2001 |

|I1 |Regulations 6, 7, |General identification requirements |

| |32-35, 36 (1)-(7) |These controls relate to the duties of suppliers and persons in charge of AQUABAC xt 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 AQUABAC xt must ensure it is labeled as required by regulations 18, and 20 (secondary identifiers for ecotoxic substances) of the Identification regulations (see|

| | |below) before supplying it to any other person. |

| | | |

| | |Regulation 7 – Identification duties of persons in charge |

| | | |

| | |Persons in charge of AQUABAC xt must ensure it is identified by regulations 18 and 20 (secondary identifiers for ecotoxic substances) of the Identification regulations (see |

| | |below) and that this label information is available to any person handling the substance within 10 seconds (regulation 33). |

| | |Regulations 32 and 33 – Accessibility of information |

| | | |

| | |All secondary identifier information (as required by regulations 18 and 20) must be available within 10 seconds, eg 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; the information provided |

| | |must be readily understandable and any written information must be in English, the information must be able to be easily read or perceived under normal lighting conditions |

| | |and (in the case of packages of >5 kg) at a distance of not less than 0.5m, and these requirements must continue to be met throughout the lifetime of the (packaged) substance|

| | |under the normal conditions of storage, handling and use. |

|I9 |Regulation 18 |Secondary identifiers for all hazardous substances |

| | |This control relates to detail required for AQUABAC xt 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. |

|I11 |Regulation 20 |Secondary identifiers for ecotoxic substances |

| | |This control relates to the additional label detail required for AQUABAC xt. 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 that when used in any region where species of native mosquitoes are only found in that region, application should occur in such a way that populations of those |

| | |native mosquitoes will not be adversely affected. |

| | |These requirements could be addressed by statements on the label with respect to its action against both target and non-target organisms and the method of application used to|

| | |avoid exposure to non-target organisms. |

|I19 |Regulations |Alternative information in certain cases |

| |29 – 31 |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 – 25 when substances are contained in |

| | |fixed bulk containers or bulk transport containers. |

| | |Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that |

| | |identifies the type and general degree of hazard of the substance. |

| | |Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if the substance is labelled or marked in compliance with the requirements of the |

| | |Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. |

| | | |

| | | |

| | |Regulation 30 – Substances in multiple packaging |

| | |This regulation relates to situations when hazardous substances are in multiple packaging and the outer packaging obscures some or all of the required substance information. |

| | |In such cases, the outer packaging must: |

| | |be clearly labelled with all relevant priority identifier information 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 label assigned by the UN Model Regulations. |

| | | |

| | |Regulation 31 – Alternative information when substances are imported |

| | |This regulation relates to alternative information requirements for hazardous substances that are imported into New Zealand in a closed package or in a freight container and |

| | |will be transported to their 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. |

|I21 |Regulations |Documentation required in places of work |

| |37–39, 47–50 |These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Material 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 substances of specific hazard classifications are held in the workplace in |

| | |quantities exceeding the levels as specified in Schedule 2 of the Identification Regulations. |

| | | |

| | |For AQUABAC xt the trigger level is 50L. |

|I29 |Regulations |Duties of persons in charge of places with respect to signage |

| |51 – 52 |These controls specify the requirements for signage, in terms of content, presentation and positioning at places where hazardous substances are held in quantities exceeding |

| | |those specified in Schedule 3 of the Identification Regulations. |

| | | |

| | |For AQUABAC xt the trigger level is 10,000 L. |

| |Hazardous Substances (Packaging) Regulations 2001 |

|P1 |Regulations 5, 6, |General packaging requirements |

| |7(1), 8 |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 AQUABAC xt with any previous contents of the packaging. |

|P3 |Regulation 9 |Packaging requirements for substances packed in limited quantities |

| | |When certain hazardous substances are packaged in limited quantities, there is provision for them to be packaged to a lesser performance standard (as specified in Schedule 4 |

| | |of the Packaging Regulations) than normally required. A list of those hazardous substances, and the maximum quantity of substance per package, that may be packaged to this |

| | |lesser performance standard is provided in Schedule 5. |

| | | |

| | |For AQUABAC xt the maximum quantity per package for which this regulation applies is 450 L. |

| |Hazardous Substances (Disposal) Regulations 2001 |

|D5 |Regulations 9 |Disposal requirements for toxic and ecotoxic substances |

| | |AQUABAC xt must be disposed of by: |

| | |treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does |

| | |not include dilution of the substance with any other substance prior to discharge to the environment, or |

| | |discharging the substance to the environment provided that after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone |

| | |does not exceed any EELwater (environmental exposure limit) set by the Authority for that substance. |

| | |exporting the substance from New Zealand as a hazardous waste |

|D6 |Regulation 10 |Disposal requirements for packages |

| | |This control gives the disposal requirements for packages that contained AQUABAC xt 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. |

|D7 |Regulations 11, 12 |Information requirements |

| | |These controls relate to the provision of information concerning disposal (essentially on the label) that must be provided when selling or supplying a quantity of a hazardous|

| | |substance that exceeds the trigger levels as specified in Schedule 1 of the Disposal Regulations. Where a substance triggers more than one hazard classification, the most |

| | |stringent quantity generally applies. |

| | | |

| | |For AQUABAC xt the trigger level is 1 L. |

| | | |

| | |Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, ie that would not |

| | |comply with the Disposal Regulations. Such information must be accessible to a person handling the substance within 10 seconds and must comply with the requirements for |

| | |comprehensibility, clarity and durability as described in Regulations 34-36 of the Identification regulations (control code I1). |

|D8 |Regulations 13, 14 |Documentation requirements |

| | |These controls relate to the provision of documentation concerning disposal (essentially in a MSDS) that must be provided when selling or supplying a quantity of a hazardous |

| | |substance that exceeds the trigger levels as specified in Schedule 2 of the Disposal Regulations. |

| | | |

| | |For AQUABAC xt the trigger level is 50 L. |

| | | |

| | |The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such |

| | |documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and |

| | |clarity as described in Regs 48 (2), (3) and (4) of the Identification regulations (control code I21). |

| |Hazardous Substances (Emergency Management) Regulations 2001 |

|EM1 |Regulations 6, 7, 9 – |Level 1 emergency management information: General requirements |

| |11 |These controls relate to the provision of emergency management information (essentially on the label) that must be provided with any hazardous substance when present in |

| | |quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management Regulations. |

| | | |

| | |Regulation 6 describes the duties of suppliers, regulation 7 describes the duties of persons in charge of places, regulation 9 describes the requirement for the availability |

| | |of the information (10 seconds) and regulation 10 gives the requirements relating to the presentation of the information with respect to comprehensibility, clarity and |

| | |durability. These requirements correspond with those relating to secondary identifiers required by the Identification regulations (code I1, regulations 6, 7, 32 – 35, 36(1) |

| | |- (7)). |

| | | |

| | |Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. |

|EM7 |Regulation |Information requirements for ecotoxic substances |

| |8(f) |The following information must be provided with ecotoxic substances when present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency |

| | |Management Regulations. |

| | |a description of the parts of the environment likely to be immediately affected by it |

| | |a description of its typical effects on those parts of the environment |

| | |a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment |

| | | |

| | |Refer to Sections 9.8 and 9.9 of this decision, Schedule 1 is incomplete. It is recommended that appropriate emergency management information is included on the label above |

| | |the (intended) trigger quantity of 1 L. |

|EM8 |Regulations 12–16, |Level 2 emergency management information requirements |

| |18–20 |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 |

| | |Material Safety Data Sheets). This documentation must be provided where hazardous substances are sold or supplied, or held in a workplace, in quantities equal to or greater |

| | |than the quantities specified in Schedule 2 (Emergency Management Regulations). |

| | | |

| | |For AQUABAC xt the trigger level is 50 L. |

| | | |

| | |Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of |

| | |complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the|

| | |documentation. |

| | | |

| | |Regulation 18 provides accessibility requirements (documentation to be available within 5 minutes) and regulation 19 provides requirements for presentation with respect to |

| | |comprehensibility and clarity. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). |

|EM11 |Regulations |Level 3 emergency management requirements – emergency response plans |

| |25 – 34 |These regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where hazardous substances are held (or |

| | |reasonably likely to be held on occasion) in quantities equal to or greater than those specified in Schedule 4 (Emergency Management Regulations). |

| | | |

| | |For AQUABAC xt the trigger level is 10,000 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 – 30. Requirements relating to the availability of equipment, materials and people are provided in regulation 31, |

| | |requirements regarding the availability of the plan are provided in regulation 32 and requirements for testing the plan are described in regulation 33. |

|EM12 |Regulations |Level 3 emergency management requirements – secondary containment |

| |35 – 41 |These regulations relate to the requirement for a secondary containment system to be installed at any fixed location where liquid (or liquefiable) hazardous substances are |

| | |held in quantities equal to or greater than those specified in Schedule 4 of the Emergency Management Regulations. Where a substance triggers more than one hazard |

| | |classification, the most stringent quantity generally applies. |

| | | |

| | |For AQUABAC xt the trigger level is 10,000 L. |

| | | |

| | |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). |

|EM13 |Regulation 42 |Level 3 emergency management requirements – signage |

| | |These controls relate to the provision of emergency management information on signage at places where hazardous substances are held at quantities equal to or greater than the|

| | |quantities specified in Schedule 5. Where a substance triggers more than one hazard classification, the most stringent quantity generally applies. |

| | | |

| | |For AQUABAC xt the trigger level is 10,000 L. |

| | | |

| | |The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the |

| | |Identification Regulations. |

-----------------------

[1] Default controls are set under section 77 of the HSNO Act and the associated Hazardous Substances regulations.

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hïfön 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 ERMA New Zealand and is also contained in the ERMA New Zealand User Guide to the Controls Regulations.

[4] 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.

[5] These explanations are for guidance only. Refer to the cited regulations for the formal specification, and for definitions and exemptions.

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