ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 1 August 2006 Application Code HRC05001 Application Type To reassess any hazardous substance under the Hazardous Substances and New Organisms Act 1996 Applicant The Chief Executive, ERMA New Zealand Date Application Received 24 March 2006 Submission Period 28 March 2006 -12 May 2006 Hearing 22 June 2006 Consideration 23 June 2006 Considered by A Committee of the Authority Purpose of the Application To reassess soluble concentrates containing hydrogen cyanamide (520-540 g/litre) 1 Summary of Decision 1.1 Following consideration of the application for reassessment, the importation or manufacture of soluble concentrates containing hydrogen cyanamide (520-540 g/litre) is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology). 1.2 The substance has been given the following unique identifier for the ERMA New Zealand Hazardous Substances Register: soluble concentrates containing hydrogen cyanamide (520-540 g/litre) 1.3 This reassessment covers all substances fitting the definition including the trade name products: Hi-Cane (Nufarm Ltd); Breaker (Nufarm Ltd); Gro-Chem HC50 (Gro-Chem NZ Ltd), Hortcare Hi-break (Grosafe Chemicals Ltd); Cyan (Gro-Chem NZ Ltd); TreeStarT (Island Agriculture Ltd). The proprietors of these products are referred to as “registrants” in this decision as the trade name products must be registered under the Agricultural Compounds and Veterinary Medicines Act 1997 before they can be used in New Zealand. 1.4 The substance is referred to as “hydrogen cyanamide” in this decision. 2 Legislative Criteria for Application 2.1 The application was lodged by the Chief Executive pursuant to section 63 of the Act following grounds for reassessment having been established under section 62 of the Act by the Authority in its decision dated 6 August 2004. This reassessment decision was determined in accordance with section 29, taking into account additional matters to be considered in that section and matters relevant to the purpose of the Act, as 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 application was formally received on 24 March 2006. 3.2 In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public notification was made on 28 March 2006 (on ERMA New Zealand’s web site) and the application was advertised in the four main newspapers (New Zealand Herald, Dominion Post, Christchurch Press and Otago Daily Times) on 8 April 2006. 3.3 Submissions closed on 12 May 2006, 30 working days after public notification. 3.4 Various government departments (including the New Zealand Food Safety Authority (Agricultural Compounds & Veterinary Medicines Group), the Ministry of Health and the Department of Labour (Work Place Group)), Crown Entities and other interested parties, which in the opinion of the Authority would be likely to have an interest in the application, were notified of the receipt of the application (sections 53(4) and 58(1)(c), and clauses 2(2)(e) and 5) and provided with an opportunity to comment or make a public submission on the application. 3.5 In response the Agency received: 3.6 further information from the registrant of a hydrogen cyanamide product; comments from the Ministry of Health, the New Zealand Food Safety Authority, and MAF Policy; and 899 other submissions. The 899 submissions comprised: 24 substantive submissions; and 875 pro-forma submissions made by individuals in support of the submission made by NZ Kiwifruit Growers Inc. 3.7 No external experts were used to review the information contained in the application (clause 17). 3.8 A public hearing was held in Mount Maunganui on 22 June 2006. ERMA New Zealand Decision: Application HRC05001 Page 2 of 43 3.9 A Committee appointed under paragraph 43 of Schedule 1 to the Act (and acting under a delegation made under section 19(2)(b)) comprising Mr Tony Haggerty (Chairperson), Professor George Clark, Dr Max Suckling and Ms Bella Tuau, heard and considered the application. 3.10 The information available to the Committee comprised: the application, including confidential appendices; the submissions; the Agency’s Summary of Submissions and Supplementary Report; information presented at the hearing. 4 Consideration Purpose of the Application 4.1 The purpose of the application was to reassess the importation and manufacture of soluble concentrates containing hydrogen cyanamide (520-540 g/litre). Sequence of the Consideration 4.2 In accordance with clause 24, the approach adopted by the Committee was to: establish the hazard classification for hydrogen cyanamide and derive the default controls. identify potentially non-negligible risks, costs, and benefits. assess potentially non-negligible risks, costs, and benefits in the context of the default controls and possible variations to those controls. Risks were assessed in accordance with clause 12, and costs and benefits in accordance with clause 13. consider and determine variations to the default controls arising from the circumstances provided for in sections 77A and 77(3), (4) and (5) and then consolidate controls. evaluate overall risks, costs, and benefits (adverse and beneficial effects) to reach a decision. The combined impact of risks, costs and benefits was evaluated in accordance with clause 34, and the cost-effectiveness of the application of controls was considered in accordance with clause 35. The Authority’s approach to risk was considered in accordance with clause 33. ERMA New Zealand Decision: Application HRC05001 Page 3 of 43 Hazard Classification 4.3 In the application, the applicant reviewed the available data on the hazardous properties of the substance and classified it accordingly. The applicant’s classifications and the classifications that were applied to the substance when it was transferred to the HSNO regime are as follows: Acute toxicity (oral) Acute toxicity (dermal) Acute toxicity (inhalation) Skin Irritancy Eye Irritancy Contact Sensitisation Human reproductive or developmental Toxicity Human Target organ toxicity Aquatic Toxicity Terrestrial Vertebrate Ecotoxicity Terrestrial Invertebrate Ecotoxicity 4.4 Classification as Transferred 6.1C 6.1D 6.1D 6.3A 6.4A 6.5B 6.8B Applicant’s Classification 6.1C 6.1D 6.1D 6.3A 6.4A 6.5B 6.8B 6.9B (harmful) 9.1D (slightly harmful) 9.3B - 6.9A (toxic) 9.1D (slightly harmful) 9.3B 9.4C (harmful) The Committee agrees with the revised classifications determined by the applicant and classifies the substance accordingly. Default Controls 4.5 Based on the hazard classifications as determined by the Committee, a set of associated controls has been identified. These default controls, expressed as control codes1, are listed in Table 1. 4.6 The following controls relate to terrestrial vertebrate pest control. As the substance is not used for this purpose, these controls have not been considered any further: 4.7 Control T8, specifying the requirements for class 6.1 substances that are (lawfully) laid or applied outdoors for terrestrial vertebrate pest control. Control E4, which applies to class 9.3 substances which are intentionally released into the environment in granular form or coated on seeds for terrestrial vertebrate pest control. Additional controls may be added under section 77A in order to manage the risks associated with hydrogen cyanamide which are not addressed by the default controls. These additional controls are considered later in this decision. 1 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. ERMA New Zealand Decision: Application HRC05001 Page 4 of 43 Table 1: Default Controls 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. T3 Requirements for keeping records of use T4 Requirements for equipment used to handle substances T5 Requirements for protective clothing and equipment T6 Approved handler/security requirements for certain toxic substances 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 E2 Restrictions on use of substances in application areas E3 Controls relating to protection of terrestrial invertebrates eg beneficial insects E6 Requirements for equipment used to handle substances Identification Controls I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability I3 Priority identifiers for ecotoxic substances I8 Priority identifiers for toxic 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 I20 Durability of information for class 6.1 substances I21 General documentation requirements I23 Specific documentation requirements for ecotoxic 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 P13 Packaging requirements for toxic 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 and corrosive 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 ERMA New Zealand Decision: Application HRC05001 Page 5 of 43 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. Lifecycle of Hydrogen Cyanamide 4.8 Hydrogen cyanamide is not currently manufactured in New Zealand but is imported in 200 L drums or in 20 L retail packs in standard 20ft shipping containers and transported to facilities at Mount Maunganui, Auckland and Porirua. 4.9 The 200 L drums are labelled for distribution in New Zealand or are repackaged into UN approved 20 L HDPE containers. 4.10 Distribution is handled by a national freight forwarding company and commercial operators who specialise in carrying dangerous goods. The substance is delivered to Nelson, Bay of Plenty, Hawke’s Bay and North Auckland regions. Delivery is to a combination of packhouses, farms and merchant stores. In the case of packhouses and merchant stores, these organisations organise local delivery to orchards. 4.11 Typically the products are received in July prior to spraying in late July/August. During the application period 200 L containers are typically transported by a truck which follows a sprayer from orchard to orchard. 4.12 The registrants recommend that empty drums are triple rinsed and then returned to the distributors for reuse. Use of hydrogen cyanamide on kiwifruit 4.13 There are some 2700 kiwifruit growers in New Zealand. They are distributed in New Zealand as follows: Nelson, 5%, Southern North Island 1%, Hawke’s Bay 1%, Gisborne 2%, Waikato 3%, Auckland 4%, Northland 4%, and Bay of Plenty 80%. 4.14 Fruit production from Hayward (Green) and Hort16A (Gold) vines is highly dependent on the number of buds that break in spring and the number of flowers each bud produces. Kiwifruit vines require sufficient winter chilling to ensure adequate budbreak and flowering. Cool temperatures (below 7°C) during May, June and July advance and increase the percentage of winter buds that break, while cool temperatures in June and July increase the number of flowers that are present on the vine. Seasonal variation in winter temperature in the Bay of Plenty and more northerly kiwifruit growing regions can have a major impact on the productivity of the vines. ERMA New Zealand Decision: Application HRC05001 Page 6 of 43 4.15 Hydrogen cyanamide is routinely used as a management tool on both Green and Gold vines to promote budbreak and flowering of kiwifruit vines. The recommended application period for Green is between the last week of July and 24 August and for Gold the optimum timing is mid-late July. Treated vines respond with: an increased percentage bud break an earlier bud break an increase in the number of flowers an increase in king flowers and reduction in unwanted lateral flowers (known as doubles and trebles) a compact flowering period an earlier leaf canopy removal of lichen and scale insects. 4.16 The combined impact of all these responses is a significant increase in the yield of the vines, reduced management costs and larger fruit. 4.17 The suppliers’ recommended use of hydrogen cyanamide is by a single application at a dilution of 4-6 L per 100 L of water and rate of 500-700 L spray volume per hectare, not exceeding 800 L spray volume per hectare as damage can occur at higher rates. The spray is prepared by adding the required amount of hydrogen cyanamide to a half filled spray tank, adding the remainder of water and agitating thoroughly before and during spray application. The highest concentration of hydrogen cyanamide should be used at the beginning of the application period. A lower concentration within the recommended range may be used as the application period progresses. Addition of a non-ionic wetting agent to the formulated product is recommended by the suppliers to improve coverage. 4.18 Application of hydrogen cyanamide is by a fine spray mist delivered by an air blast sprayer at low pressure. All dormant buds must be sprayed to ensure even effects. Spray should reach into the central leader and cover the inner canopy. Use of hydrogen cyanamide on apples 4.19 Approximately 10% of the use of hydrogen cyanamide is on apple crops for similar purposes. Recommended use is by the preparation of a spray at a dilution of 2.5 L per 100 L water, and applying the spray at a rate of 800-1300 L per hectare, depending on tree size. Application is via fine spray mist to ensure complete tree coverage, 30-45 days before natural budbreak (50% greentip on spurs). Use Classification 4.20 ERMA New Zealand has adopted the European Union use classification system as the basis for recording the nature and uses of substances approved. The following use categories are recorded for this substance: Main Category: 4 Wide-dispersive use Industrial category: 1 Agricultural industry Function/Use category: 38 Pesticides ERMA New Zealand Decision: Application HRC05001 Page 7 of 43 Identification of the Significant Risks, Costs and Benefits (adverse and beneficial effects) of the Substance 4.21 The Committee identified potentially non-negligible risks, costs and benefits by reference to clauses 9 and 11, which incorporate relevant matters referred to in sections 2, 5, 6, and 8. 4.22 A “cost” is defined in regulation 2 of the Methodology as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. Therefore these have been assessed in an integrated fashion together with risks in the following assessment of adverse effects. Identification of Risks and Costs to Human Health 4.23 Hydrogen cyanamide triggers the following hazardous property classifications that are relevant to the consideration of risks to human health: 6.1C oral toxicity; 6.1D dermal toxicity; 6.1D inhalation toxicity; 6.3A skin irritancy; 6.4A eye irritancy; 6.5B contact sensitisation; 6.8B suspected human or reproductive toxicity; and 6.9A target organ systemic toxicity. 4.24 As discussed in the application, a “cyanamide flush” effect in humans can occur if alcohol is consumed 24 hours prior to, or up to seven days following, use of hydrogen cyanamide formulations. The “cyanamide flush” is characterised by symptoms such as skin flushing, dizziness, headache, shortness of breath and a rapid pulse. 4.25 In addition, potentially significant risks to human health might arise from exposure of people to hydrogen cyanamide as a result of the following activities: accidents during repackaging, transportation or storage; and use of the substance or drift of spray from the target site. Identification of Risks and Costs to the Environment 4.26 The hazardous properties of hydrogen cyanamide that are of relevance to the environment are: 9.1D aquatic ecotoxicity; 9.3B terrestrial vertebrate ecotoxicity; and 9.4C terrestrial invertebrate ecotoxicity. 4.27 Therefore, if the substance were to be released into the environment, exposure to it could potentially lead to harmful effects on aquatic organisms, terrestrial vertebrates and terrestrial invertebrates. These could arise from: accidents during importation, transportation or storage; dilution or use that results in incorrect dilution rates or application rates; inappropriate use of the substance or drift of spray from the target site; or run-off into waterways following application of the substance. ERMA New Zealand Decision: Application HRC05001 Page 8 of 43 Identification of Risks and Costs to Society and the Community 4.28 The adverse social effect on individuals and communities associated with anxiety about the inappropriate use of hydrogen cyanamide is considered to be potentially significant. Identification of Risks and Costs to the Market Economy 4.29 No potentially significant adverse effects on the economy were identified from the use of hydrogen cyanamide. Identification of Risks and Costs to Māori 4.30 No potentially significant adverse effects to the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga were identified from the use of hydrogen cyanamide. Identification of Benefits 4.31 A “benefit” is defined in regulation 2 of the Methodology as “the value of a particular positive effect expressed in monetary or non-monetary terms”. Benefits may arise from any of the matters set out in clauses 9 and 11. Benefits are beneficial effects as described in the Act. Identification of Benefits to the Environment and Human Health 4.32 No potentially significant benefits to human health or the environment resulting from the availability of hydrogen cyanamide were identified. Identification of Benefits to the Market Economy 4.33 Since the substance is currently available, the benefits of its use are known. The following potentially significant benefits of the substance being available for use by the kiwifruit industry have been identified: promotion of even bud break, with the consequential increase in flowering and fruit yield; shorter flowering period; removal of lichen and scale insects; spread of the crop load more evenly over the whole vine; reduced management costs; reduced biennial bearing; and a longer growing season and larger fruit for a given fruit load. 4.34 Benefits for apple growers include: advancement and compression of flowering which allows thinning to be better timed; reduction in fire blight risk; and earlier harvest and better prices. 4.35 The production impact of hydrogen cyanamide also contributes towards a satisfactory export yield and has an influence on the size of fruit and in the timing of fruit being ready to market. ERMA New Zealand Decision: Application HRC05001 Page 9 of 43 Identification of Benefits to Society and Community 4.36 The social and community beneficial effects of the availability of hydrogen cyanamide, particularly the flow-on effects of employment are considered to be potentially significant. Identification of Alternative Substances 4.37 The Committee notes that, in assessing the grounds for reassessment of the substance, the Authority concluded that there were no viable alternative substances available that would achieve the same end result. Assessment of Significant Risks, Costs and Benefits (Adverse and Beneficial effects) 4.38 In accordance with clause 11, the Committee considered the effects of hydrogen cyanamide through its lifecycle and the risks, costs and benefits flowing from its hazardous properties. 4.39 The risks assessed were those identified as potentially non-negligible. These risks were considered in terms of the requirements of clause 12, including the assessment of magnitude of consequences and probabilities (likelihoods), the impact of uncertainty and the impact of risk management. Assessment of Risks and Costs to Human Health 4.40 As the acute toxic effects to the skin (6.1D dermal, 6.3A skin irritancy) and eyes (6.4A eye irritancy) are most likely to rise from a single exposure they have been considered separately from the acute oral (6.1C) and the chronic effects (6.5B contact sensitisation; 6.8B suspected human or reproductive toxicity; and 6.9A target organ systemic toxicity) in the following discussion. Repackaging 4.41 After taking into account provisions for controlling spillage, the requirement for protective clothing and equipment and the controls in place under the Health and Safety in Employment Act 1992, the Committee considers it improbable that exposure of workers or others to hydrogen cyanamide will occur during repackaging. If exposure did occur, the magnitude of any acute effects to the skin or eyes that may result is considered to be moderate. The Committee is satisfied that the overall level of acute toxic risks to the skin or eyes associated with the repackaging of hydrogen cyanamide is low. 4.42 The Committee considers that exposure to hydrogen cyanamide during repackaging could also lead to major acute oral toxic effects or chronic effects to workers’ health. However, taking into account the HSNO provisions for controlling spillage and the requirement to use protective clothing and equipment and the controls in place under the Health and Safety in Employment Act 1992, the Committee is satisfied that it is highly improbable that exposure will occur and thus the overall level of acute oral toxic and chronic risks to human health and safety associated with the repackaging of hydrogen cyanamide is assessed as low. ERMA New Zealand Decision: Application HRC05001 Page 10 of 43 Transportation 4.43 Where there is an accident involving bulk transport of hydrogen cyanamide, the magnitude of any effect will depend on the quantity spilled and the extent to which workers and others are exposed to the substance. Bulk containers hold or carry a larger volume, but are designed to do so and a spill will not necessarily eventuate if an accident does occur. While people could suffer eye or skin irritation if protection is not worn, the Committee considers it very unlikely that this will eventuate. As the acute skin and eye effects on human health are considered to be moderate, the residual risk is assessed as medium. While exposure to this risk is involuntary, the committee notes that the risk will not persist over time, it is not subject to uncontrollable spread, the potential adverse effects are reversible and the risk is reasonably well known. Therefore, the Committee did not consider it necessary to adopt a more risk averse approach in respect of transportation risks to bystanders. 4.44 Distribution of hydrogen cyanamide for retail sale is generally in containers of 20 L or 200 L capacity; in these circumstances the packaging controls will provide a barrier against exposure. Accordingly, the occurrence of acute toxic effects (such as eye or skin irritation) or chronic effects on human health are considered highly improbable; the magnitude of any effect is considered to be moderate and therefore the residual risk is very low. 4.45 The Committee also considers it highly improbable that workers or the public will ingest enough of the substance following a transport incident to suffer adverse acute oral toxic effects or chronic effects. Accordingly, the overall level of acute oral toxic and chronic risks to human health and safety associated with the transport of hydrogen cyanamide is assessed as low. Storage 4.46 During commercial storage (including storage at merchant stores), hydrogen cyanamide will be handled by approved handlers who are people with knowledge, training and experience in the handling of this substance and others similar to it. In these circumstances, the Committee considers that the likelihood of adverse effects arising from accidental spillage is highly improbable and, if it does occur, to be moderate in effect. The residual risk, with the controls in place, is therefore very low. 4.47 The Committee also considers it highly improbable that people handling hydrogen cyanamide during commercial storage will ingest enough of the substance following accidental spillage to suffer adverse acute oral toxic effects or chronic effects. Accordingly, the overall level of acute oral toxic and chronic risks to human health and safety associated with the commercial storage of hydrogen cyanamide is assessed as low. 4.48 Storage at an orchard may pose risks if the substance can be accessed by children or other people who have no knowledge of the substance or who are not in a position to make use of the information provided about it. However, with the controls in place, especially the requirement that the substance be secured so that a person cannot gain access to it unless the person has a key or other device used for operating locks, it is considered improbable that children or others will be exposed to the substance. As the ERMA New Zealand Decision: Application HRC05001 Page 11 of 43 effects of such an exposure, if it should occur, would be moderate, the Committee is satisfied that overall risk in this situation is low. 4.49 The Committee also considers it highly improbable that children or others will ingest enough of the substance following accidental spillage to suffer adverse acute oral toxic effects or chronic effects. Accordingly, the overall level of acute oral toxic and chronic risks to human health and safety associated with the storage of hydrogen cyanamide on an orchard is assessed as low. Use 4.50 The applicant has used models to assess exposure arising from the use of hydrogen cyanamide containing products and compared the output to toxicity values to determine the risk to operators and other people who may be affected through spray drift (referred in this decision as “bystanders”). Assessment of Operator Risk 4.51 The applicant carried out exposure modelling based on scenarios involving no protective clothing and with protective clothing during mixing and loading and spray application. Taking this modelling into account, the Committee considers that hydrogen cyanamide poses a medium toxicity risk to workers. However, this level of risk will be greatly affected by the standard of protective equipment used. If industry best practices are employed, then the level of residual risk will be reduced. 4.52 The Committee considers the HSNO controls most relevant in addressing the risks posed to workers as those relating to 4.53 the competency of the applicators; personal protective equipment; labelling; equipment for handling the substance; and workplace exposure standards. Competency. The HSNO control T6 (Regulation 9 of the Hazardous Substances (Classes 6, 8 and 9) Controls Regulations 2001) requires that hydrogen cyanamide be under the control of an approved handler. Requiring hydrogen cyanamide to be under the control of properly qualified personnel at all times is seen as a key control in addressing the risks associated with the use of the substance. The applicant proposed that minimum GROWSAFE qualifications should be prescribed for approved handlers. However, the Committee notes that the HSNO Code of Practice (NZS 8409: The Management of Agrichemicals) and the Regional Air Plans already list these as requirements. Accordingly, the Committee is of the view that the approved handler controls need not be varied so as to provide minimum qualifications. The Committee also considers that it is the responsibility of the test certifier who is issuing the approved handler test certificate to ensure that the candidate has knowledge of the effects of hydrogen cyanamide and the measures required to ensure that the substance is used safely in accordance with the HSNO approval. ERMA New Zealand Decision: Application HRC05001 Page 12 of 43 4.54 Personal Protective Equipment. The Committee agrees with the applicant that, if the appropriate protective equipment is utilised, the residual risk to workers is low as it reduces the likelihood that operators will be exposed to hydrogen cyanamide. The following equipment is recommended by suppliers of hydrogen cyanamide and the applicant indicated it should be prescribed as a HSNO control. an impermeable chemical resistant suit with hood (PVC or similar); gauntlet gloves (PVC, nitrile or similar); chemical resistant boots; impermeable headwear; face and eye protection; and an air purifying respirator with a filter suitable for aerosol particles. 4.55 While the Committee agrees that this standard of personal protective equipment is appropriate, it does not consider that the HSNO control T5 (Regulation 8 of the Hazardous Substances (Classes 6, 8, and 9) Controls Regulations 2001) needs to be modified. The Committee is of the view that it is the responsibility of the people in charge of the spraying (usually an approved handler) to ensure that the workers are using the correct standard of equipment and notes that a failure for this to happen constitutes a breach of this control. 4.56 Labelling. Under the Hazardous Substances (Identification) Regulations 2001, hydrogen cyanamide labels must contain information on the hazards associated with the substance. As the cyanamide flush reaction is not specifically identified as a hazard under the Act, the Committee is of the view that the following statement should be included on hydrogen cyanamide labels to reduce the likelihood that this risk will occur: Do not consume alcohol the day before or up to seven days after application. In combination with alcohol, a severe temporary reaction known as “cyanamide flush” may be produced. Symptoms of cyanamide flush include skin flushing, dizziness, headache, shortness of breath and a rapid pulse. 4.57 Equipment for handling the substance. The HSNO Control T4 (Regulation 7 of the Hazardous Substances (Classes 6, 8 and 9) Controls Regulations 2001) requires that equipment used to handle hydrogen cyanamide must retain and/or dispense the substance in the manner intended. The applicant proposed a variation to this control that would require that the spray equipment should be calibrated on an annual basis. While the Committee accepts that this is good practice, it does not consider that varying control T4 to require such calibration will necessarily reduce the level of risk to workers. The Committee considers that these risks are best addressed by ensuring that workers are competent to carry out the spraying operations (see 4.53 above). 4.58 Workplace Exposure Standards. On transferring hydrogen cyanamide to the HSNO regime, the Authority adopted a workplace exposure standard for hydrogen cyanamide. The Committee considers that this standard remains appropriate and should continue to apply. This value is: WES-TWA2 for hydrogen cyanamide (active) 2 mg/m3 2 The WES-TWA is the time-weighted average (8 hours/day, 5 days/week) exposure standard designed to protect the worker from the long-term effects of exposure. ERMA New Zealand Decision: Application HRC05001 Page 13 of 43 Length of exposure period 4.59 The Authority, in considering the Grounds for Reassessment (decision dated 6 August 2004) concluded that there has been a significant change in use of hydrogen cyanamide. The development of the gold kiwifruit market (Gold) has caused the spraying period for hydrogen cyanamide to be extended beyond that of the traditional kiwifruit (Green), by a further two to three weeks. 4.60 The Committee accepts that, as the 28-day study has been used as a worst-case scenario in the exposure modelling, the longer potential exposure period for workers to hydrogen cyanamide has been adequately addressed in assessing the level of risk to workers. Re-entry time following use 4.61 The Committee notes that there are insufficient data available to calculate a re-entry period. However, it is noted that re-entry periods are already specified on the labels of several hydrogen cyanamide products whereby workers who are in contact with kiwifruit canes within 5 days of spraying should wear gloves, and it is also good husbandry practice not to enter treated fields until the plants and soil are dry, unless the users are wearing protective clothing. 4.62 Accordingly, provided that the label recommendations are retained and adhered to following re-entry, and that personal protective equipment is worn, the Committee is satisfied that the likelihood of exposure occurring is improbable. As the magnitude of any effects is moderate, the risks to workers following re-entry are considered to be low. Overall Assessment of risks to operators. 4.63 From the discussion in paragraphs 4.53 to 4.62 above, the Committee is satisfied that application of the key HSNO controls identified in paragraph 4.52 above, particularly the approved handler and personal protective equipment requirements, will be adequate to ensure the level of risk to operators is low. Assessment of risks to bystanders 4.64 The applicant noted that the majority of effects relating to humans via spray drift have been associated with skin irritation and sensitisation. While these are clearly effects resulting from acute exposure to spraying it is not possible to carry out a quantitative assessment of the level of risk that the spraying of hydrogen cyanamide poses to the health of bystanders. 4.65 Overall, the Committee agrees with the applicant that, if hydrogen cyanamide is used in conditions that minimise the likelihood of spraydrift such as low wind and with adequate buffer zones in place, the risk of adverse effects to bystanders arising from spraydrift is low. 4.66 In considering the application, the Committee considered the effectiveness of the current regulatory regime in addressing the level or risk from spraydrift and whether any of the controls should be varied or additional controls prescribed. The key ERMA New Zealand Decision: Application HRC05001 Page 14 of 43 considerations in assessing the reduction of risk to bystanders are discussed in paragraphs 4.67 to 4.81 below. 4.67 Competency. The Committee considers that a key HSNO control in ensuring the level of risk to bystanders is minimised is to ensure that applicators are well trained and supervised. As discussed above in paragraph 4.53 above the Committee is of the view that the current HSNO approved handler control should ensure that applicators have appropriate qualifications and that their competency has been assessed as satisfactory or they are properly supervised. 4.68 Tolerable Exposure Limits (TELs). The Committee notes the concerns expressed about the measurability and enforceability of TELs. The Committee further notes that ERMA New Zealand is considering a range of issues to do with the use of TELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. Accordingly, the Committee is not setting any TELs in relation to this substance at this time. 4.69 Application technology. Zespri International Ltd and New Zealand Kiwifruit Growers Inc. indicated that research in the kiwifruit industry has focused on developing and modifying application methods for hydrogen cyanamide. The results of trials on spray adjuvants and the use of air inclusion nozzles conducted in 2005 are significant, with some of the treatments trialled reducing spray drift by as much as 85 percent. Larger scale trials will be completed in 2006 aimed at implementation in 2007/08. 4.70 Ongoing trials are being undertaken to confirm the results and to verify the efficacy before recommendations are made to the wider industry through an industry wide education programme. The intention is to publish a best practice manual by June 2009. However, the industry submitters indicated that the uptake of new technology could happen much sooner if the trials confirm the efficacy of the technology. 4.71 The Committee agrees that there is significant potential in the adoption of new technologies. Accordingly, the Committee considers that ERMA New Zealand should monitor the reporting of incidents over the next 5 years to assess the effectiveness of changes in technology and the impact of the regulatory controls. The Committee notes that at this time, or at any time beforehand, the Authority could consider whether there are any further grounds for reassessing hydrogen cyanamide again. 4.72 Industry Self-Regulation. In its submission, New Zealand Kiwifruit Growers Inc (NZKGI) referred to its spray complaint investigation service. Its key goal is to encourage compliance with Regional Council and HSNO requirements. To this end NZKGI runs a 0800 hot line for complaints and also receives details of complaints from the Regional Councils. 4.73 For a repeat or serious offence, there is potential for the matter to be referred to Zespri International Ltd (Zespri). Zespri will assess the complaint against its Crop Protection Programme and EUREPGAP standard and implement a sanction process, if applicable, and consider implementation of a penalty. Penalties can include ineligibility for export, a 20 cent per class one tray deduction or a market access hold being placed on the class one fruit coming off the orchard where the incident occurred. ERMA New Zealand Decision: Application HRC05001 Page 15 of 43 4.74 Because of the current integrated nature of the kiwifruit industry, the Committee accepts that industry self-regulation is an effective tool in ensuring hydrogen cyanamide users comply with the Act and other regulatory requirements. However, if this were to change the Authority could consider whether there was a need to review how well the controls are being complied with. 4.75 Complaint reporting. The Committee notes that NZKGI has an effective procedure for dealing with complaints. However, the regional councils and the Ministry of Health may also receive complaints. The Committee considers that the various agencies should review the collating and sharing of information relating to spraydrift incidents. 4.76 Under section 148 of the Act, the Authority is required to report annually on the number and type of incidents caused by the inadequate management of hazardous substances. To assist in this reporting, ERMA New Zealand has asked enforcement agencies to provide individual reports on all significant incidents relating to hazardous substances. 4.77 It is the view of the Committee that all substantiated incidents relating to chemical trespass by hydrogen cyanamide should be treated as “significant” and thus reported to ERMA New Zealand. 4.78 Notification. The Act and Regulations do not prescribe any controls relating to the notification of people who may be potentially be affected by spraydrift. However, the Environment Bay of Plenty and other Regional Air Plans include notification requirements. As these are enforceable under the Resource Management Act 1991 and meet the definition of ‘controls’ under the Act, the Committee does not consider that it is appropriate to duplicate them here. 4.79 However, the Committee notes that some affected people did not appear to be aware of their rights and the appropriate action to take, if a spray drift incident occurs or if they have concerns about being exposed to the chemical. To this end, the Committee strongly recommends that the key stakeholders (particularly the registrants, regional councils, Zespri International and industry associations, such as the NZKGI), undertake a public awareness programme for persons who may be potentially affected by spray drift from hydrogen cyanamide. The programme should ensure that people are aware of the notification requirements and what action they can take if they believe that a spray drift incident has occurred. 4.80 Record keeping. HSNO control T3 (Regulations 5(1) and 6 of the Hazardous Substances (Classes 6, 8 and 9) Regulations 2001) requires that a person using hydrogen cyanamide must keep written records of each use if the application is in an area where members of the public may be present, or where the substance is likely to enter air and leave the place. This record should include: name of the substance; date and time of each application; amount of substance applied; location where applied; a description of the wind speed and direction; and name and address of the user. ERMA New Zealand Decision: Application HRC05001 Page 16 of 43 4.81 The Committee does not consider any additional requirements are warranted but recommends that industry works towards the eventual adoption and inclusion of electronic recording of weather conditions as part of these records. Overall Assessment of risks to bystanders. 4.82 From the discussion in paragraphs 4.67 to 4.81 above, the Committee is satisfied that the risks to bystanders can be adequately managed by the HSNO controls, particularly the approved handler requirements; controls under the RMA such as the notification requirements; and industry self-regulation. However, to ensure that bystanders are aware of what action to take should spraydrift occur, the Committee has recommended that a public awareness programme be undertaken (see paragraph 4.139 below). Assessment of risks and costs to the environment 4.83 Taking into account the HSNO controls in place for hydrogen cyanamide (particularly packaging and emergency management controls) the Committee considers it highly improbable that an incident will occur during the repackaging, transport or storage of hydrogen cyanamide that will lead to an adverse effect occurring in the environment. If an adverse effect results, the magnitude is expected to be minimal to minor due to the small quantity of substance likely to be released and the nature and size of the area affected. Hence, the resulting risk is insignificant. 4.84 The Committee notes that no exposure monitoring data relevant to assessing the risks of hydrogen cyanamide on the environment have been identified. However, no effects on wildlife attributable to use of hydrogen cyanamide have been reported. 4.85 Based on conservative modelling carried out by the applicant, the magnitude of the risk quotients indicates a low to medium acute and high chronic toxicity risk to the environment. While exposure to this risk is involuntary, the Committee notes that the risk will not persist over time, it is not subject to uncontrollable spread, the potential adverse effects are reversible and the risk is reasonably well known. Therefore, the Committee did not consider it necessary to adopt a more risk averse approach in respect of risks to the environment arising from the use of hydrogen cyanamide. 4.86 The Committee notes the potential risks to the environment but considers that the risks are adequately addressed by the existing HSNO controls, particularly, approved handler requirements, restriction of use to avoid exposure of beneficial insects (control E3) and requirements for equipment used to handle hazardous substances (control E6). Assessment of risks and costs to society and the community 4.87 One potentially significant adverse social and community effect has been identified: the effect on individuals and communities associated with anxiety resulting from the inappropriate use of hydrogen cyanamide. The Committee assessed the magnitude of these effects as being minor as, if they do occur, it is only for a short period of the year. Given the actions being taken by the industry and other groups to ameliorate them, the Committee considered that the likelihood that these effects will occur as being improbable. Accordingly, the level of risk is assessed as very low. ERMA New Zealand Decision: Application HRC05001 Page 17 of 43 4.88 As discussed above the Regional Council Air Plans and NZS 8409:2004 Management of Agrichemicals provide an extensive range of notification controls and signage controls to provide the community with information and choice about exposure to hydrogen cyanamide. In addition the kiwifruit industry has established an 0800 number complaints procedure. These activities appear to have assisted in reducing the level of incidents being reported. However, the Committee acknowledges that there are still some tangible impacts on some individuals. Accordingly, as discussed above, the Committee considers that ERMA New Zealand should monitor the reporting of incidents over the next 5 years. The Committee notes that at the end of this time, or at any time beforehand, if there is evidence of significant adverse effects on the community the Authority could consider whether there are any further grounds for reassessing hydrogen cyanamide again. 4.89 With these measures in place, the Committee is of the view that, while the risks and costs to society and the community are very low, the level of incidents and complaints should be monitored to determine whether the situation is maintained. Assessment of Benefits (Beneficial Effects) to the Market Economy 4.90 Hydrogen cyanamide increases the total number of flowers while removing the lateral flowers on the vine. The production impact of these changes is to increase the export yield while also having influence on the size of fruit and in the timing of fruit being ready to market. ZESPRI International has calculated the impact of not having the use of hydrogen cyanamide for the production of Green and Gold kiwifruit on the grower and industry economic returns. They consider that a calculated loss of $163.6 million per annum to the industry would occur if hydrogen cyanamide was no longer available and this would result in a loss to the New Zealand economy of in the order of $410.6 million per year. 4.91 The Ministry of Agriculture and Forestry agreed with industry’s assertion that the overall economic benefit of using hydrogen cyanamide is very large, and should hydrogen cyanamide be unavailable, the impact on economic viability of the kiwifruit (and to a lesser extent, the apple) industry would be very high. 4.92 Taking these economic data into account, the Committee has assessed the level of benefit associated with the continued availability of hydrogen cyanamide as massive. Assessment of Benefits (Beneficial Effects) to Māori 4.93 The Committee notes that there are a significant number of Māori orchardists and the majority of these are in warm coastal areas where there is not enough winter chilling to achieve the same level of bud break that may be achieved in other areas. 4.94 As indicated by one of the submitters, the incomes from orchards are used to directly support Iwi and are vital income streams to support elders, education programmes, and economic and social development. In addition, emphasis was placed by the submitter on the importance of the viability of the orchards in retaining the land for future generations. 4.95 The Committee accepts that a benefit of the use of hydrogen cyanamide to Māori is very likely to result from the economic success of the industry based on the use of hydrogen ERMA New Zealand Decision: Application HRC05001 Page 18 of 43 cyanamide. The overall level of benefit to the relationship of Māori with their taonga is thus assessed as high. Assessment of Benefits (Beneficial Effects) to Society and Communities 4.96 As discussed in the application, the kiwifruit sector presently accounts for 19.2% of Bay of Plenty economic activity. It is clear that the total impact of kiwifruit production on the Bay of Plenty regional economy extends beyond the immediate direct impact from kiwifruit production and sales. 4.97 It is estimated that there are 25,000 to 30,000 permanent and seasonal workers in the kiwifruit industry in the Bay of Plenty. Although the industry has increasingly become an employer of skilled labour, it still remains a significant employer of unskilled labour. 4.98 Thus there are major social benefits associated with the continuing success of the kiwifruit industry in the Bay of Plenty and in other areas. The Committee accepts that, because there are no effective alternatives, the use of hydrogen cyanamide is crucial for maintaining kiwifruit production at current levels and thus supporting local communities. If there were to be a significant reduction in the level of production of kiwifruit and a subsequent reduction in skilled and unskilled employment in the Bay of Plenty as a result of hydrogen cyanamide not being available, then there would be significant flow-on effects to the affected communities. 4.99 The Committee agrees that similar effects would be seen in other areas highly dependent on kiwifruit and apple production (noting that apple growing areas may be somewhat less vulnerable as there are more likely to be alternative substances available). 4.100 If hydrogen cyanamide were not available, then there would be minor to major adverse social effects (major in the Bay of Plenty and minor overall), and this effect would be very likely. Converting this to a beneficial effect associated with the availability of the substance and using the ERMA New Zealand qualitative tables, the Committee is of the view that the level of beneficial effect is high to very high depending on the location of the impact. Likely Effects of the Substance Being Unavailable 4.101 The largest market for hydrogen cyanamide is the kiwifruit industry, and to a lesser extent, the apple industry. The Committee accepts that requirements for a plant growth regulator that effectively promotes even budbreak and the consequential increase in flowering and fruit yield is extremely important to the success of the industry. Hydrogen cyanamide is currently seen to be the only plant growth regulator that is effective. 4.102 If hydrogen cyanamide were unavailable, the Committee accepts that a significant number of kiwifruit orchards would become unprofitable and cease production. The economic impact on the Bay of Plenty ($340 million) and nationally on the industry ($410 million) would also be extremely high. In addition, there is also likely to be a longer term impact on the kiwifruit industry as its premium position will be affected or lost entirely through the industry’s inability to continue to service customer requirements due to reduced and variable fruit supply and quality. The consequence of ERMA New Zealand Decision: Application HRC05001 Page 19 of 43 this into the future would be lower returns per tray and a significantly smaller market share. Alternative Substances 4.103 In its decision on the determination as to whether there are grounds for reassessing hydrogen cyanamide containing products, the Authority stated: “An alternative substance registered under the Agricultural Compounds and Veterinary Medicines Act for use as a plant growth regulator for kiwifruit does not appear to be an appropriate substitute for hydrogen cyanamide in some situations. The Committee therefore concludes that grounds do not exist under section 62(2)(b)”. 4.104 As no further or new information on alternative substances having been provided to it, the Committee accepts that, at the present time, there are no viable alternative products available. Overall Evaluation of Risks, Costs and Benefits Precautionary Approach 4.105 Section 7 and Clause 29 require the Committee to take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects and to consider the materiality of the uncertainty to the decision. 4.106 The Committee concluded that there was little uncertainty associated with the adverse effects that were assessed as significant and that this uncertainty was not material to the decision Approach to Risk 4.107 Clause 33 requires the Authority, when considering applications, to have regard to the extent to which a specified set of risk characteristics exist. While the approach to risk has been considered in terms of individual risks, it should also be addressed in terms of the overall evaluation. The intention of this provision is to provide a route for determining how cautious or risk averse the Authority should be in weighing up adverse and beneficial effects. In evaluating risks assessed as being significant (non-negligible) the Committee considered these characteristics and considered their impact on the magnitude of the adverse effects. 4.108 Two risks were assessed as medium; bystander exposure during transportation incidents, and risks to the environment during use of the product. Exposure to both of these risks is involuntary. However, they will not persist over time, they are not subject to uncontrollable spread, the potential adverse effects are reversible and the risks are reasonably well known. Therefore, the Committee did not consider it necessary to adopt a more risk averse approach in respect of these risks. 4.109 However, because of the toxicity of hydrogen cyanamide and the reports of adverse effects occurring, the Committee adopted a cautious and risk averse position when considering the risks to bystanders from the use of hydrogen cyanamide and hence the recommendation to increase public awareness that appears in paragraph 4.139 below. ERMA New Zealand Decision: Application HRC05001 Page 20 of 43 4.110 Having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and section 29, risks, costs and benefits were evaluated taking account of all proposed controls including default controls plus proposed variations to the controls. 4.111 Clause 34 sets out the approaches available to the Authority in evaluating the combined impact of risks, costs and benefits, i.e. weighing up risks, costs and benefits. 4.112 In accordance with clause 34, the Committee considers that the substance poses a negligible to medium risk to the environment, to human health, to Māori, to society and to the economy. As the Committee is satisfied that the adverse effects of hydrogen cyanamide can be adequately managed by the controls that apply, and as the economic, social and community benefits are very high, the Committee considers that the overall level of risks and costs associated with hydrogen cyanamide are outweighed by the benefits. Additional Controls under s77A 4.113 Under section 77A of the Act, 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 that apply to the substance: (a) the proposed control is more effective in terms of its effect on the management, use and risks of the substance; or (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of the substance; or (c) the proposed control is more likely to achieve its purpose. 4.114 Given the scope of section 77A and the basis of the substance’s risk assessment, the Committee has applied the following additional controls to hydrogen cyanamide: 4.115 The following statement shall appear on hydrogen cyanamide labels and in accompanying documentation: Do not consume alcohol the day before or up to seven days after application. In combination with alcohol, a severe temporary reaction known as “cyanamide flush” may be produced. Symptoms of cyanamide flush include skin flushing, dizziness, headache, shortness of breath and a rapid pulse. 4.116 The following regulation is to be inserted immediately after regulation 9 of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001. 9A Exception to approved handler requirement for transportation of packaged hydrogen cyanamide (1) Regulation 9 is deemed to be complied with if: (a) when hydrogen cyanamide is being transported on land— (i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system under section 6D of the Transport Services Licensing Act 1989 or a safety ERMA New Zealand Decision: Application HRC05001 Page 21 of 43 system which is referred to in an approved safety case under the Railways Act 2005; and (ii) every other case, the person who drives, loads, and unloads the vehicle that is transporting the substance – (A) for hire or reward, or in quantities which exceed those set out Schedule 1 of the Land Transport Rule 45001/1: Dangerous Goods 2005, has a current dangerous goods endorsement on his or her drivers licence; or (B) in every other case, the Land Transport Rule 45001/1:Dangerous Goods 2005 is complied with; or (b) in the case of hydrogen cyanamide being transported by sea, one of the following is complied with: (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A); or (ii) International Maritime Dangerous Goods Code; or (c) when this substance being transported by air, Part 92 of the Civil Aviation Rules is complied with. (2) Subclause (1)(a)— (a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 applies; but (b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations. (3) Subclause (1)(c)— (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but (b) does not apply to the storage and handling of this substance in any place that is not within an aerodrome, or within an aerodrome by non-airline ground personnel; (4) In this regulation, UN Model Regulations means the 14th revised edition of the Recommendation on the Transport of Dangerous Goods Model Regulations, published in 2005 by the United Nations. 4.117 The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767, as amended by Supplements to the New Zealand Gazette, 1 October 2004, No. 128, page 3133, 16 December 2005, No. 208, page 5289, 27 June 2006, No. 70, page 1609 76, 30 June 2006, No. 76, page 2409) shall apply to this substance, notwithstanding clause 1(1) of that schedule. 4.118 The Committee notes that, as a means of managing the risks from hydrogen cyanamide, additional controls relating to stationary container systems are necessary. These provisions are currently provided in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 as amended. ERMA New Zealand Decision: Application HRC05001 Page 22 of 43 4.119 The following subclauses shall be added after subclause (3) of regulation 36 of the Hazardous Substances (Emergency Management) Regulations 2001: (4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a secondary containment system. (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. 4.120 The Committee considers that these controls are relevant to this substance, and notes that no other such controls have been specified under the Act. In accordance with section 77A(4)(a) of the Act, the Committee is satisfied that imposing these additional controls is more effective than any other specified controls in terms of their effect on the management, use and risks of hydrogen cyanamide. Addressing Risks to Human Health, the Environment and the Community - Bonds 4.121 Bonds. The Sustainability Council of New Zealand submitted that a performance bond should be a requirement and that only those who meet this requirement may use the substance. The bond would be specified to cover any damage to human health, damage to the environment, or financial damage that is the result of the use of the substance when this damage occurs beyond the property specified for its application. In the Council’s view bonds should be provided by importers and distributors who should then obtain ‘back to back’ bonds from those using/spraying the substance and the process for setting the level of bond should be consistent with international best practice. 4.122 The Committee notes that the Act makes no specific provision for requiring such bonds when approving substances under the Act, and there is uncertainty as to the legal ability to impose bonds for hazardous substances. This situation may be contrasted with the Resource Management Act 1991 (RMA). The RMA specifically, and in some detail, enables consent authorities to impose a requirement for a bond on a resource consent to ensure that one or more of its conditions are complied with. 4.123 If a requirement for a bond were to be imposed it would need to be as an additional control under section 77A. To impose an additional control under section 77A, the Authority must be satisfied that, against any other specified controls that apply to the substance under the Act: (a) the proposed control is more effective in terms of its effect on the management, use and risks of the substance; or ERMA New Zealand Decision: Application HRC05001 Page 23 of 43 (b) the proposed control is more cost-effective in terms of its effect on the management, use and risks of the substance; or (c) the proposed control is more likely to achieve its purpose. 4.124 As discussed above, the Committee considers that the risks to bystanders and the environment can be adequately managed by the use and enforcement of HSNO controls, (particularly the approved handler requirements); and controls under the RMA (such as the notification requirements). 4.125 The Committee considers that placing a performance bond requirement on importers and distributors would be ineffective as they do not use the substance and therefore have no control over the circumstances in which it is applied. If a bond requirement were to be set, it would need to apply to the growers who use hydrogen cyanamide. However, the number of users and their distribution would seem to make this impractical. There would be difficulty in obtaining evidence and proving liability (for example, was the damage caused by hydrogen cyanamide, and if so, which user did it come from? What is the appropriate level of bond and would this change according to the location of the property?) A complex bond scheme would need to be established, which would create additional costs. At this scale it may take on hallmarks of a compensation fund, which is beyond the function of a control under the Act. 4.126 The Act carries substantial penalties for breaches of controls – up to 3 months’ imprisonment or a fine of up to $500,000. Reports of cross boundary damage from hydrogen cyanamide appear to be caused by use of the substance in unsuitable weather conditions or without due care. The Committee does not consider that the addition of a performance bond requirement would be more likely to prevent such damage than other specified controls such as approved handler requirements? 4.127 Overall, the Committee is of the view that a control requiring performance bonds would not be more effective or cost effective in terms of its effect on the management, use and risks of hydrogen cyanamide than other controls that require the substance to be used safely. Nor would such a control be more likely to achieve its purpose. 4.128 Accordingly, the Committee is not satisfied that a performance bond control would meet the section 77A criteria, and declines to impose such a control to hydrogen cyanamide. Variation of Controls under Section 77 4.129 Under section 77(3), (4) and (5), the default controls determined by the hazardous properties of the substance may be varied. 4.130 The Committee decided that the following variations should apply to hydrogen cyanamide: 4.131 Control T1 relates to the requirement for limiting exposure to hydrogen cyanamide through the setting of acceptable daily exposure values (ADEs) potential daily exposure values (PDEs) and tolerable exposure limits (TELs). The Committee has set the following ADE and PDEs for hydrogen cyanamide (active): ERMA New Zealand Decision: Application HRC05001 Page 24 of 43 4.132 4.133 ADE = 0.002 mg/kg bw/day PDE (dermal exposure) = 0.0008 mg/kg bw/day PDE (inhalation exposure) = 0.0008 mg/kg bw/day PDE (food) = 0.0004 mg/kg bw/day. ERMA New Zealand is considering a range of issues related to the introduction of TELs including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. Accordingly, the Committee is not setting any TELs in relation to hydrogen cyanamide at this time. Control T2 relates to the requirement to set Workplace Exposure Standards (WESs). The Committee considers that this standard set on transfer of hydrogen cyanamide should apply. This value is: WES-TWA3 for hydrogen cyanamide (active) 2 mg/m3 4.134 Controls T4 and E6 are combined as they both relate to the same regulation pertaining to requirements for equipment used to handle hazardous substances. 4.135 Control E1 requires that Environmental Exposure Limits (EELs) are established for hydrogen cyanamide. The Committee notes that ERMA New Zealand is considering a range of issues to do with EELs, including their setting, measurement and enforcement following the passage of amendments to the Act in December 2005. Accordingly, the Committee has not set any EELs in relation to hydrogen cyanamide at this time and the default EELs set under Regulation 32 have been deleted. 4.136 Controls P3 and P13 are combined as they both relate to the packaging requirements for hydrogen cyanamide. It is noted that control P13 takes precedence as it sets the most stringent packaging requirements; however, the allowances from P3 have been included for lesser quantities. 4.137 Controls D4 and D5 are combined as they all relate to disposal requirements for the substance. Recommendations 4.138 The Committee recommends that, should inappropriate or accidental use, transport or disposal of hydrogen cyanamide result in the contamination of waterways, the appropriate authorities, including the relevant iwi authorities in the region, should be notified. This action should include advising them of the contamination and the measures taken in response. 4.139 The Committee strongly recommends that key stakeholders undertake a public awareness programme that is aimed at ensuring (as a minimum) that occupiers of neighbouring properties know: the period when spraying is likely to occur; that a spray plan will be available from the sprayer on request; 3 The WES-TWA is the time-weighted average (8 hours/day, 5 days/week) exposure standard designed to protect the worker from the long-term effects of exposure. ERMA New Zealand Decision: Application HRC05001 Page 25 of 43 that they will receive further detailed information of the intention to spray before the intended use; that they may, by written agreement with the sprayer, arrange to have more or less frequent information about spraying of hydrogen cyanamide provided; and the details of the relevant person to contact at the regional council in the event of a spray drift incident (in the case of the kiwifruit industry this should also include the NZ Kiwifruit Growers Industry 0800 number currently 0800 232 505). Environmental User Charges 4.140 The Committee considers that use of controls on hydrogen cyanamide is an effective means of managing risks associated with this substance. At this time no consideration has been given to whether or not environmental charges should be applied to this substance as an alternative or additional means of achieving effective risk management. 5 Decision 5.1 Pursuant to section 29 of the Act, the Committee has considered this application to reassess a hazardous substance made under section 63 of the Act. 5.2 The Committee is satisfied that the controls, as varied in paragraphs 4.113 to 4.137 are appropriate to manage the adverse effects of the hazardous substance. 5.3 Having considered the information provided and all the possible effects of the hazardous substance, and having taken into account the application of controls in accordance with section 29 of the Act, the view of the Committee is that the substance poses negligible to medium risks to the environment and to human health and safety, and massive benefits to the economy. As some of the risks are non-negligible, the Committee considered the application in accordance with clause 27 and is satisfied that the benefits (beneficial effects) associated with the substance outweigh the risks and costs (adverse effects). 5.4 In accordance with clause 36(2)(b) of the Methodology the Committee records that, in reaching this conclusion, it has applied the balancing tests in section 29 of the Act and clause 27 of the Methodology. 5.5 It has also applied the following criteria in the Methodology: clause 9 - equivalent of sections 5, 6 and 8; clause 11 – characteristics of substance; clause 12 – evaluation of assessment of risks; clause 13 – evaluation of assessment of costs and benefits; clause 14 – costs and benefits accruing to New Zealand clause 21 – the decision accords with the requirements of the Act and regulations; clause 22 – the evaluation of risks, costs and benefits – relevant considerations; clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; ERMA New Zealand Decision: Application HRC05001 Page 26 of 43 5.6 clause 25 – the evaluation of risks; clause 27 – risks and costs versus benefits; clause 33 – risk characteristics; clause 34 – the aggregation and comparison of risks, costs and benefits; and clause 35 – the costs and benefits of varying the default controls. The application for the reassessment of the hazardous substance hydrogen cyanamide is thus approved, with controls as detailed in Appendix 1. Tony Haggerty Date 1 August 2006 Chair ERMA New Zealand Approval Code: soluble concentrates containing hydrogen cyanamide (520-540 g/litre) ERMA New Zealand Decision: Application HRC05001 HRC000001 Page 27 of 43 Appendix 1: List of Controls for hydrogen cyanamide Control Codes and Explanations Control Code4 Regulation5 Explanation6 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T1 11-27 Limiting exposure to toxic substances This control relates to limiting public exposure to toxic substances through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure (ADE)/reference dose (RfD) values. An ADE / RfD value must be set for a toxic substance if: it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and it is a substance to which people are likely to be exposed to during their lifetime; and exposure is likely to result in an appreciable toxic effect. If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns. The following ADE and PDEs for hydrogen cyanamide (active) have been set ADE = 0.002 mg/kg bw/day PDE (dermal exposure) = 0.0008 mg/kg bw/day PDE (inhalation exposure) = 0.0008 mg/kg bw/day PDE (food) = 0.0004 mg/kg bw/day. T2 29, 30 TELs have not been set at this time. Controlling exposure in places of work A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work. WES-TWA for hydrogen cyanamide (active) 2 mg/m3 4 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 5 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. 6 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. ERMA New Zealand Decision: Application HRC05001 Page 28 of 43 Control Code4 T3 Regulation5 5(1), 6 T4, E6 7 T5 8 T6 9 Explanation6 Requirements for keeping records of use A person using hydrogen cyanamide for the purposes of causing biocidal action must keep written records of each use if the application is in an area where members of the public may be present, or where the substance is likely to enter air or water and leave the place. The information to be provided in the record is described in Regulation 6(1). The record must be kept for a minimum of three years following the use and must be made available to an enforcement officer on request. Requirements for equipment used to handle hazardous substances Any equipment used to handle hydrogen cyanamide (e.g. spray equipment) must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved. Requirements for protective clothing and equipment Protective clothing/equipment must be employed when hydrogen cyanamide 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 should be used, and the requirements for maintaining the clothing/equipment. Approved handler requirements Where hydrogen cyanamide is held or used in any quantity, it must be under the personal control of an approved handler, or locked up. However, it may be handled by a person who is not an approved handler if: an approved handler is present at the facility where the substance is being handled; and the approved handler has provided guidance to the person in respect of handling; and the approved handler is available at all times to provide assistance if necessary. The following regulation is inserted immediately after regulation 9: 9A Exception to approved handler requirement for transportation of packaged pesticides ((1) Regulation 9 is deemed to be complied with if: (a) when hydrogen cyanamide is being transported on land— (i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system under section 6D of the Transport Services ERMA New Zealand Decision: Application HRC05001 Page 29 of 43 Control Code4 Regulation5 Explanation6 Licensing Act 1989 or a safety system which is referred to in an approved safety case under the Railways Act 2005; and (ii) every other case, the person who drives, loads, and unloads the vehicle that is transporting the substance – (A) for hire or reward, or in quantities which exceed those set out Schedule 1 of the Land Transport Rule 45001/1: Dangerous Goods 2005, has a current dangerous goods endorsement on his or her drivers licence; or (B) in every other case, the Land Transport Rule 45001/1:Dangerous Goods 2005 is complied with; or (b) in the case of hydrogen cyanamide being transported by sea, one of the following is complied with: (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A); or (ii) International Maritime Dangerous Goods Code; or (c) when this substance being transported by air, Part 92 of the Civil Aviation Rules is complied with. (2) Subclause (1)(a)— (a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 applies; but (b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations. (3) Subclause (1)(c)— (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but T7 10 (b) does not apply to the storage and handling of this substance in any place that is not within an aerodrome, or within an aerodrome by nonairline ground personnel; (4) In this regulation, UN Model Regulations means the 14th revised edition of the Recommendation on the Transport of Dangerous Goods Model Regulations, published in 2005 by the United Nations. Restrictions on the carriage of hazardous substances on passenger service vehicles The maximum quantity per package of hydrogen cyanamide permitted to be carried on passenger service vehicles is 0.1 L. ERMA New Zealand Decision: Application HRC05001 Page 30 of 43 Control Code4 Regulation5 Explanation6 Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 Limiting exposure to ecotoxic substances This control relates to the setting of environmental exposure limits (EELs). An EEL establishes the maximum concentration of an ecotoxic substance legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition). EELs have not been set at this time and the default EELs do not apply. E2 46-48 Restrictions on use within application area These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6, Regulation 9) do not apply once the substance has been applied or laid. In recognition of the need to limit adverse effects within the target area, Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. E3 E5 49 5(2), 6 As EELs have not been set, an application rate has not been set at this time. Controls relating to protection of terrestrial invertebrates e.g. beneficial insects This Regulation applies to substances that are ecotoxic to terrestrial invertebrates (class 9.4 substances) and prescribes controls to restrict the use of such substances in situations where they may poses a high risk to beneficial invertebrates e.g. honeybees. Specifically, a person must not apply hydrogen cyanamide: in an area where bees are foraging and the substance is in a form in which bees are likely to be exposed to it; or on specific plants likely to be visited by bees if the plant is in open flower or part bloom, or is likely to flower within a specified period of time following application of the substance (not longer than 10 days). Requirements for keeping records of use A person using a substance that is hydrogen cyanamide for the purposes of causing biocidal action must keep written records of that use if 3 kg or more of the substance is applied within 24 hours in an area where the substance is likely to enter air or water and leave the place. The information to be provided in the record is described in Regulation 6(1). The record must be kept for a minimum of three ERMA New Zealand Decision: Application HRC05001 Page 31 of 43 Control Code4 Regulation5 Explanation6 years following the use and must be made available to an enforcement officer on request. Hazardous Substances (Identification) Regulations 2001 The Identification Regulations prescribe requirements with regard to identification of hazardous substances in terms of: information that must be “immediately available” with the substance (priority and secondary identifiers). This information is generally provided by way of the product label; documentation that must be available in the workplace, generally provided by way of SDS; signage at a place where there is a large quantity of the substance. I1 6, 7, 32-35, General identification requirements 36 (1)-(7) These controls relate to the duties of suppliers and persons in charge of hazardous substances with respect to identification (essentially labelling) (Regulations 6 and 7), accessibility of the required information (Regulations 32 and 33) and presentation of the required information with respect to comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7)) Regulation 6 – Identification duties of suppliers Suppliers of any hazardous substance must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8-17) and secondary identifier information (as required by Regulations 18-30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information available within 10 seconds (Regulation 33). Suppliers must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to. Regulation 7 – Identification duties of persons in charge Persons in charge of any hazardous substance must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling the substance within two seconds (Regulation 32), and the secondary identifier information is available within 10 seconds (Regulation 33). Persons in charge must also ensure that no information is supplied with the substance (or its packaging) that suggests it belongs to a class or subclass 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. ERMA New Zealand Decision: Application HRC05001 Page 32 of 43 Control Code4 Regulation5 I3 9 I8 14 I9 18 I11 20 Explanation6 Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary: any information provided (either written or oral) must be readily understandable and in English; any information provided in written or pictorial form must be able to be easily read or perceived by a person with average eyesight under normal lighting conditions; any information provided in an audible form must be able to be easily heard by a person with average hearing; any information provided must be in a durable format i.e. the information requirements with respect to clarity must be able to be met throughout the lifetime of the (packaged) substance under the normal conditions of storage, handling and use. Priority identifiers for ecotoxic substances This requirement specifies that hydrogen cyanamide must be prominently identified as being ecotoxic. This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Priority identifiers for certain toxic substances This requirement specifies that hydrogen cyanamide must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance and the need to restrict access to the substance by children. This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label. Secondary identifiers for all hazardous substances This control relates to detail required for hydrogen cyanamide 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 hydrogen cyanamide. This information must be accessible within 10 seconds ERMA New Zealand Decision: Application HRC05001 Page 33 of 43 Control Code4 Regulation5 I16 25 Explanation6 (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 of hazard (e.g. ecotoxic to terrestrial vertebrates; harmful to terrestrial invertebrates). Secondary identifiers for toxic substances This control relates to the additional label detail required for hydrogen cyanamide. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided: an indication of its general type and degree of toxic hazard (eg acutely toxic (oral, dermal, inhalation); irritating to the skin; irritating to the eyes; contact sensitiser; suspected human reproductive or developmental toxicity; toxic to human target organs). 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 hydrogen cyanamide (active) The following shall appear on hydrogen cyanamide label: I18 27 I19 29-31 Do not consume alcohol the day before or up to seven days after application. In combination with alcohol, a severe temporary reaction known as “cyanamide flush” may be produced. Symptoms of cyanamide flush include skin flushing, dizziness, headache, shortness of breath and a rapid pulse. 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). Alternative information in certain cases Regulation 29 – Substances in fixed bulk containers or bulk transport containers This Regulation relates to alternative ways of presenting the priority and secondary identifier information required by Regulations 8 to 25 when substances are contained in fixed bulk containers or bulk transport containers. Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance. When class 1, 2, 3, 4 or 5 substances are contained, there is an additional requirement that information must be provided describing any steps to be taken to prevent an unintentional ERMA New Zealand Decision: Application HRC05001 Page 34 of 43 Control Code4 Regulation5 Explanation6 explosion, ignition combustion, acceleration of fire or thermal decomposition. Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if the substance is labelled or marked in compliance with the requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. Regulation 30 – Substances in multiple packaging This Regulation relates to situations when 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 i.e. the hazardous properties of the substance must be identified; or be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant; or in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background); or bear the relevant class or subclass label assigned by the UN Model Regulations. I20 36(8) I21 37-39, 47-50 Regulation 31 – Alternative information when substances are imported This Regulation relates to alternative information requirements for a hazardous substance that is imported into New Zealand in a closed package or in a freight container and will be transported to its destination without being removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is labelled or marked in compliance with the requirements of the Land Transport Rule 45001. Durability of information for class 6.1 substances Any packaging in direct contact with hydrogen cyanamide must be permanently identified as having contained a toxic substance, unless the substance as packaged is restricted to a place of work. Documentation required in places of work These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets) (Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation 48). These controls are triggered when hydrogen cyanamide is held in the workplace in quantities equal to or greater than 0.1 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 a hazardous substance equal ERMA New Zealand Decision: Application HRC05001 Page 35 of 43 Control Code4 Regulation5 Explanation6 to or greater than 0.1 L, if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person. Regulation 38 – Documentation duties of persons in charge of places of work The person in charge of any place of work where 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 a hazardous substance must include the following information: the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); a description of the physical state, colour and odour of the substance; if the substance’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the changes in physical state may occur and the nature of those changes; in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur; contact details for the New Zealand supplier / manufacturer /importer; all emergency management and disposal information required for the substance; the date on which the documentation was prepared; the name, concentration and CAS number of hydrogen cyanamide. Regulation 47 – Information not included in approval This Regulation relates to the provision of specific documentation information (e.g. as provided on an SDS). If information required by Regulations 39 to 46 was not included in the information used for the approval of the substance by the Authority, it is sufficient compliance with those Regulations if reference is made to that information requirement along with a comment indicating that such information is not applicable to that substance. Regulation 48 – Location and presentation requirements for documentation All required documentation must be available to a person handling the ERMA New Zealand Decision: Application HRC05001 Page 36 of 43 Control Code4 Regulation5 Explanation6 substance in a place of work within 10 minutes. The documentation must be readily understandable by any fully-trained worker required to have access to it and must be easily read, under normal lighting conditions, at a distance of not less than 0.3 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 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 hydrogen cyanamide must include the following information: its general degree and type of ecotoxic hazard (e.g. slightly harmful to the aquatic environment; ecotoxic to terrestrial vertebrates; harmful 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 toxic substances must include the following information: its general degree and type of toxic hazard; (e.g. acutely toxic (oral, dermal, inhalation); irritating to the skin; irritating to the eyes; contact sensitiser; suspected human reproductive or developmental toxicity; toxic to human target organs). a full description of the circumstances in which it may harm human beings; the kinds of harm it may cause to human beings; a full description of the steps to be taken to prevent harm to human beings; if it will be a liquid during its use, the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured; a summary of the available acute and chronic (toxicity) data used to define the (toxic) subclass or subclasses in which it is classified; the symptoms or signs of injury or ill health associated with each likely route of exposure; the dose, concentration, or conditions of exposure likely to cause ERMA New Zealand Decision: Application HRC05001 Page 37 of 43 Control Code4 Regulation5 Explanation6 injury or ill health; any TELs or WESs set by the Authority. The following shall appear on hydrogen cyanamide documentation: I29 51-52 Do not consume alcohol the day before or up to seven days after application. In combination with alcohol, a severe temporary reaction known as “cyanamide flush” may be produced. Symptoms of cyanamide flush include skin flushing, dizziness, headache, shortness of breath and a rapid pulse. 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 hydrogen cyanamide is held in quantities exceeding 1 000 L. Signs are required: at every entrance to the building and/or location (vehicular and pedestrian) where hazardous substances are present at each entrance to rooms or compartments where hazardous substances are present; immediately adjacent to the area where hazardous substances are located in an outdoor area. The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: advise that the location contains hazardous substances; describe the general type of hazard of each substance (e.g. flammable); where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No Smoking' warning near flammable substances). I30 53 Advertising toxic substances Any advertisement for a hydrogen cyanamide must include information that identifies the substance is toxic and indicates the need to restrict access by children. In addition, it must specify the general degree and type of hazard. Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging. Regulation 5 – Ability to retain contents Packaging for all hazardous substances 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 –10 o C to +50 oC. The packaging must also maintain its ability to retain its remaining contents if part of the contents is removed from the package and the packaging is then re-closed. The packaging in direct contact with the substance must not be significantly affected or ERMA New Zealand Decision: Application HRC05001 Page 38 of 43 Control Code4 Regulation5 Explanation6 weakened by contact with the substance such that the foregoing requirements cannot be met. Regulation 6 – Packaging markings Packages containing hazardous substances must not be marked in accordance with the UN Model Regulations unless: the markings comply with the relevant provisions of that document; and the packaging complies with the tests set out in Schedule 1, 2 or 3 (Packaging Regulations) respectively; and the design of the packaging has been test certified as complying with those tests. Regulation 7(1) – Requirements when packing hazardous substance When packing any hazardous substance, 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 Hazardous substances must not be packed in packaging that has been previously packed with substances with which it is incompatible unless all traces of the previous substance have been removed. P3, P13 9, 19 PG3 Schedule 3 PS4 Schedule 4 Regulation 9A and 9B – Large Packaging Large packaging may be used to contain hazardous substances in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003. “Large Packaging” does not include: a tank, tank wagon or transportable container (as defined in the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004; or a stationary container system, a stationary tank or a tank (as defined in the Hazardous substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004. Packaging requirements for toxic substances The packaging requirements are as follows: hydrogen cyanamide in quantities over 1 L must be packaged according to Schedule 3 (UN PGIII), but may be packaged according to either Schedule 3 or Schedule 4 when in quantities equal to or less than 1 L. This schedule describes the (minimum) packaging requirements that must be complied with for this substance 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 this substance when packaged in quantities equal to or less than 1 L. ERMA New Zealand Decision: Application HRC05001 Page 39 of 43 Control Code4 Regulation5 Explanation6 Hazardous Substances (Disposal) Regulations 2001 D4, D5 8, 9 Disposal requirements for toxic substances Hydrogen cyanamide 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 TEL (tolerable exposure limit) or any EEL (environmental exposure limit) set by the Authority for that substance; or exporting the substance from New Zealand as a hazardous waste. D6 10 Disposal requirements for packages This control gives the disposal requirements for packages that contained a hazardous substance 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 hydrogen cyanamide. D8 13, 14 Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided i.e. that would not comply with the Disposal Regulations. Such information must be accessible to a person handling the substance within 10 seconds and must comply with the requirements for comprehensibility, clarity and durability as described in Regulations 34-36 of the Identification Regulations (code I1). Disposal documentation requirements These controls relate to the provision of documentation concerning disposal (essentially in an SDS) that must be provided when selling or supplying a quantity of hydrogen cyanamide that exceeds 0.1 L. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in Regulations 48(2), (3) and (4) of the Identification Regulations (code I21). 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 any quantity of hydrogen cyanamide. ERMA New Zealand Decision: Application HRC05001 Page 40 of 43 Control Code4 Regulation5 Explanation6 Regulation 6 describes the duties of suppliers, Regulation 7 describes the duties of persons in charge of places, Regulation 9 describes the requirement for the availability of the information (10 seconds) and Regulation 10 gives the requirements relating to the presentation of the information with respect to comprehensibility, clarity and durability. These requirements correspond with those relating to secondary identifiers required by the Identification Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)). EM6 8(e) EM7 8(f) EM8 12-16, 18-20 Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. Information requirements for toxic substances The following information must be provided when hydrogen cyanamide is present in any quantity. 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 hydrogen cyanamide when present in quantities equal to or greater than 0.2 L: a description of the parts of the environment likely to be immediately affected by it; a description of its typical effects on those parts of the environment; a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment. Level 2 emergency management documentation requirements These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Safety Data Sheets). This documentation must be provided where hydrogen cyanamide is sold or supplied, or held in a workplace, in quantities equal to or greater than 0.1 L. Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when the substance is being transported, and regulation 16 specifies requirements for general contents of the documentation. EM11 25-34 Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes, be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). Level 3 emergency management requirements – emergency response plans These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where hydrogen cyanamide is held (or reasonably likely to be held on ERMA New Zealand Decision: Application HRC05001 Page 41 of 43 Control Code4 EM12 EM13 Regulation5 35-41 42 Explanation6 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 hydrogen cyanamide is held in quantities equal to or greater than 100 L. Regulation 36 prescribes requirements for secondary containment systems for pooling substances. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60 L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60 L and 450 L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450 L. Regulation 40 prescribes requirements for places where hazardous substances are held underground. Regulation 41 prescribes requirements for secondary containment systems that contain substances of specific hazard classifications, e.g. there is a requirement to prevent substances from coming into contact with incompatible materials, and a requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances are contained). Level 3 emergency management requirements – signage This control relates to the provision of emergency management information on signage at places where hydrogen cyanamide is held in quantities equal to or greater than 1 000 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. Hazardous Substances (Personnel Qualification) Regulations 2001 AH1 4-6 Approved Handler requirements Hydrogen cyanamide is required to be under the control of an approved handler during specified parts of the lifecycle. An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances. Regulation 4 describes the test certification requirements, regulation 5 describes the qualification (competency and skill) requirements and regulation 6 describes situations where transitional qualifications for approved handlers apply. ERMA New Zealand Decision: Application HRC05001 Page 42 of 43 Control Code4 Regulation5 Explanation6 See Control T6 for the approved handler control. Hazardous Substances (Tracking) Regulations 2001 TR1 4(1), 5, 6 General tracking requirements Hydrogen cyanamide is subject to tracking requirements, i.e. the location and movement of the substance must be recorded at each stage of its lifecycle until its final disposal. The person in charge of the place where the tracked substance is kept is responsible for ensuring that the necessary information is included in the record. This information to be provided is specified in Schedule 2 of the Tracking Regulations, and includes information on the identification of the approved handler, and on the identification, quantity, location and disposal of the substance. The record must meet the location and presentation requirements specified in Part 2 of the Identification Regulations, i.e. it must be accessible within 10 minutes and meet the performance standards for comprehensibility and clarity [Regulation 5(1) and (2)]. If a tracked substance is transferred to another place, the person in charge must ensure that the record is retained for a period of 12 months. If the substance has undergone treatment that results in it no longer being a tracked substance, or if it has been intentionally or unintentionally disposed of, the record must be kept for 3 years. However these requirements do not apply to places that are vehicles. [Regulation 5(3) and (4)]. Regulation 6 prescribes requirements relating to the transfer of tracked substances from one place to another. Specifically, the person in charge may only transfer the tracked substance to another place if they have received confirmation that: an approved handler is present at the place receiving the substance; the place receiving the substance meets any location test certification requirements; any place where the substance is to be held during transit complies with the relevant requirements of the Hazardous Substances (Emergency Management) Regulations and Hazardous Substances (Classes 1 to 5 Controls) Regulations. Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 The Hazardous Substances (Tank Wagons and Transportable to 43 where Containers) Regulations 2004 prescribe a number of controls relating applicable to tank wagons and transportable containers and must be complied with as relevant. Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notices Schedule 8, The controls relating to stationary container systems, as set out in DGTN Schedule 8 of the Hazardous Substances (Dangerous Goods and March 2004 Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October 2004, by Issue No. 208, 16 December 2005, by Issue No. 70, 27 June 2006 and by Issue No. 76, 27 June 2006), shall apply to this substance, notwithstanding clause 1(1) of that schedule. ERMA New Zealand Decision: Application HRC05001 Page 43 of 43