ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION 26 March 2009 Application Code HSC09004 Application Type To import into containment or manufacture in containment a hazardous substance under Section 31 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Applicant Perrys Berrys Limited Purpose of the Application To carry out field trials of a mixture of the fumigants methyl iodide and chloropicrin for the prupose of establishing the minimum effective concentration that can be used in soil fumigation. Date Application Received 25 March 2009 Consideration Date 26 March 2009 Considered by Rob Forlong, Chief Executive of ERMA New Zealand. 1 Summary of decision 1.1 The application to trial in containment the hazardous substance, Ripper 500 (stored in containment), has been approved with controls in accordance with the relevant provisions of the Act 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: Ripper 500 (field trial in containment) 2 Purpose of the Application 2.1 The applicant is seeking approval to carry out field trials of a mixture of the fumigants methyl iodide and chloropicrin (Ripper 500 – 50% chloropicrin and 50% methyl iodide) for the purpose of establishing the minimum effective concentration that can be used in soil fumigation, when VIF (virtually impenetrable film) is used to cover the fumigated soil. The applicant has noted that Ripper 500 is intended to replace methyl bromide as a pre-plant soil fumigant in strawberry crops. 2.2 A ‘full’ Part 5 application for the use of this substance as a soil fumigant in New Zealand has been received by the Authority (HSR07095). This application was formally received from Elliot Technologies Limited on 27 June 2008; further consideration of this application has been postponed pending the resolution of several issues raised by the applicant in relation to the controls that were proposed in the draft Evaluation and Review report. 3 4 Application process 3.1 The application was formally received on 26 March 2009. 3.2 Project Team: Elizabeth Morgan Advisor (Hazardous Substances) Mike Morris Reassessments Manager (Hazardous Substances) Lynne Waterson Applications Manager (Hazardous Substances) 3.3 The applicant supplied the following documents: the application; the Trial Plan (including the trial site map). 3.4 The Department of Labour, the Ministry of Health and the ACVM Group were notified that the application had been received. 3.5 The applicant was provided with a copy of the proposed controls for the Ripper 500 trial and given the opportunity to comment on them. Consideration Eligibility 4.1 The applicant is seeking to establish whether the substance Ripper 500 can be efficacious when applied at rates which are lower than that which has been proposed in the full Part 5 application (350kg Ripper 500/ha). Both the applicant and the Agency consider that the information gathered in this containment trial may be relevant to the finalising the Agency’s evaluation of the full Part 5 application. 4.2 The Agency notes the purpose of the application (see sections 2.1 and 2.2 above “research on any hazardous substance to acquire information for use in assessing that substance in accordance with this Part of the Act and “research and development on any hazardous substance”) and considers that the application may properly be considered under section 30(b) and 30(ba). Life cycle 4.3 The application form itself indicates that the Ripper 500 will be imported. However, subsequent information from the applicant has clarified that the components of the formulation will be imported (methyl iodide and chloropicrin) but that the Ripper 500 formulation will be manufactured at a site in Napier and transported to the applicant’s trial site in Wiri, Auckland. ERMA New Zealand Decision: Application HSC09004 Page 2 of 17 4.4 Once transported to the trial site, the applicant intends to store the substance at a secure dangerous goods chemical storage facility located at their growing site in Wiri, Auckland, until it is required for use in the trials. 4.5 The applicant intends to trial the substance at their commercial strawberry growing site. The trial itself will take place in rows which cover a total distance of 5400m. The width of the treated rows will be approximately 1450cm (this width is essentially dictated by the width of the VIF). 4.6 The applicant has provided a map of the trial site and has indicated that the nearest houses are at least 220m from the intended trial site. The map indicates that a tractor shed and tea room are near the intended trial site, but the trial is not located near to any sensitive environmental or human receptors. 4.7 The applicant has indicated that the trial itself will be undertaken by two licensed, experienced fumigators who are approved handlers for soil fumigation and hold controlled substance licences, issued under section 95B of the Act, for the storage and use of the fumigants dichlorpropene, methyl bromide and chloropicrin. 4.8 The soil fumigation will be completed on a single day, at the locations marked on the map submitted with the applicant’s trial plan. The soil fumigation is carried out using specialised equipment consisting of a sealed tyne fumigation unit that is calibrated to deliver the desired amount of the substance at a depth of 20 to 25 cm. During the fumigation process, the soil will be covered with VIF, which the Agency understands is intended to trap the fumigant in the soil for a longer period of time than other films; thus maximising its effectiveness in killing pests that live in the soil. 4.9 The applicant is seeking approval to carry out the trial during the period March 2009 – January 2010. The applicant has indicated that any unused substance will be returned to the supplier (Elliot Technologies). Hazardous properties 4.10 The Agency notes that containment applications only require a sufficient understanding of a substance’s hazardous properties to ensure that any risks posed can be managed by controls set under the containment provisions. 4.11 In preparing the containment application document, the applicant obtained permission from Elliot Technologies to use technical information relating to the nature of the substance, that was submitted in their full Part 5 application for the Ripper formulations. The hazard profile proposed by Elliot Technologies for Ripper 500 is as follows: 6.1C Acute toxicity (oral) 6.1C Acute toxicity (dermal) 6.1A Acute toxicity (inhalation) 6.3A Skin irritation/corrosion 8.3A Eye irritation/corrosion 6.5A Inhalation sensitisation ERMA New Zealand Decision: Application HSC09004 Page 3 of 17 6.7B Carcinogenicity 6.8B Reproductive/developmental toxicity 6.9A Target organ toxicity 9.1A Aquatic ecotoxicity 9.2A Soil ecotoxicity 9.3B Ecotoxicity to terrestrial vertebrates 9.4A Ecotoxicity to terrestrial invertebrates 4.12 Given the information assessed so far as part of the HS1 Evaluation and Review process for the Ripper full release application (HSR07095) the Agency considers that the 6.1B classification for dermal exposure is more appropriate that the 6.1C classification, and that there is insufficient data to support the 9.4A classification. 4.13 The Agency has reviewed the data and other information supplied by the applicant and considers that the information is sufficient to determine that any risks posed within the defined lifecycle of the substance in New Zealand can be managed through the application of containment controls. Identification and evaluation of the significant risks of the substance in containment 4.14 The Agency has assessed the risks to the environment, human health and welfare and Maori issues and concerns, based on the information provided in the application and on other information available to the Agency as a result of the full Part V assessment of the substance, which is currently underway. 4.15 The Agency considers that, as indicated by its hazard profile, Ripper 500 has the potential to cause adverse effects to the environment and to human health and safety. The Agency notes that the physical properties of the substance are such that if it is spilled, a toxic vapour cloud may form. Depending on the nature of the environment in which a spill occurs, the vapour cloud may or disperse rapidly or it may remain concentrated in the area, presenting a risk to organisms or people in that area. 4.16 The potential for adverse environment or human health effects exists throughout the whole lifecycle of the substance i.e. import, transport, storage, use (at the trial site) and disposal. 4.17 The Agency considers that these risks can be adequately managed for the purposes of this containment trial, provided the controls specified in Appendix 1 are strictly adhered to. 4.18 In considering the controls which are appropriate to this trial of Ripper 500, the Agency has taken into consideration the controls which are currently under development for the HS1 application. In addition to the default HSNO controls triggered by the hazard profile proposed by the Agency for Ripper 500, the Agency considers that several additional controls should also apply to this trial. These controls are given in Appendix 1. ERMA New Zealand Decision: Application HSC09004 Page 4 of 17 Māori issues and concerns 5 4.19 The Project Team considered this application using the framework contained in the ERMA New Zealand user guide “Working with Māori under the HSNO Act 1996”. 4.20 The applicant and the Agency noted that Ripper 500 triggers HSNO thresholds for toxicity and ecotoxicity and may therefore have adverse effects on the relationship of Māori to the environment, particularly with regard to the mauri of native and/or valued species and ecosystems. 4.21 Taking into account the containment measures proposed, the Agency considers any likely impact of the substance on the relationship of Māori to their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga to be negligible. In addition, because of the nature of the storage regime there is no evidence to suggest that the storage of this substance will breach the principles of the Treaty of Waitangi or inhibit the ability of iwi/ Māori to fulfil their role as kaitiaki. 4.22 This assessment is made on the condition that the substance is stored and disposed of in accordance with the explicitly stated HSNO controls, and any controls stipulated in other applicable Acts. However, should an accident result in the contamination of waterways or the environment, the applicant should notify the appropriate authorities including the relevant iwi authorities in the region. This action should include advising them of the contamination and the measures taken to contain and remedy it. Containment and controls 5.1 The Agency has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and notes that these cover the matters set out in Part III of the Third Schedule of the Act, being: to limit the likelihood of escape of any contained hazardous substances or contamination by hazardous substances; to exclude organisms from the containment area; to exclude unauthorized people from the containment area; to prevent unintended release of the substances by experimenters working with the substance; to control the effects of any accidental release of the substance; inspection and monitoring requirements; and qualifications required of the person responsible for implementing the controls. 5.2 The Project Team is satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, Ripper 500 can be adequately contained during the lifecycle of the trial proposed by the applicant. 6 Decision 6.1 I have considered this application made under section 31 and, pursuant to section 32, I am satisfied that this application is for the purposes specified in sections 30(b) ERMA New Zealand Decision: Application HSC09004 Page 5 of 17 and 30 (ba), namely research on any hazardous substance to acquire information for use in assessing that substance in accordance with Part 5 of the Act and research and development on any hazardous substance. 6.2 Having considered the risks associated with the lifecycle of the substance, I am satisfied that the controls imposed in Appendix 1 and those in place under other legislation, will result in the substance being adequately contained. Further, I consider that the controls applied are too onerous to be complied with. 6.3 The application to trial in containment the hazardous substance Ripper 500 is approved with controls as set out in Appendix 1 and in accordance with the relevant provisions of the Act and the Methodology as more specifically set out in Appendix 2. Rob Forlong Date: 26 March 2009 Chief Executive of ERMA New Zealand ERMA New Zealand Approval Code: HSC000364 Ripper 500 (field trial in containment) ERMA New Zealand Decision: Application HSC09004 Page 6 of 17 APPENDIX 1: LIST OF CONTROLS THAT APPLY TO THE HAZARDOUS SUBSTANCE, RIPPER 500 (FIELD TRIAL IN CONTAINMENT) General 1. Up to 200kg of Ripper 500 may be manufactured by Leicester’s for supply to Perrys Berrys Limited. Perrys Berrys may store up to 200kg of Ripper 500 at their dangerous goods storage facility, in Wiri, Auckland. 2. The trial shall be undertaken in accordance with the Trial Plan provided by the applicant as part of the application. No modification may be made to the Trial Plan unless it has first been approved in writing by ERMA New Zealand. 3. Access to the trial sites shall be by permission of the owner of the property on which it is located. 4. Notwithstanding the requirements of control 2 above, the trial shall also comply with the controls set out below. 5. This approval remains in place until 31 January 2010. 6. The following regulations apply to Ripper 500, with the variations as shown in Table A1.1: Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001; Hazardous Substances (Identification) Regulations 2001; Hazardous Substances (Packaging) Regulations 2001; Hazardous Substances (Disposal) Regulations 2001; Hazardous Substances (Emergency Management) Regulations 2001; and Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001. Regulation2 Control Code1 - Topic Variations Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls T1 11-27 Limiting exposure to toxic The following TELair values apply to the Ripper substances range: TELair = 0.0004 mg/m3 for chloropicrin 1 Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations. 2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only. ERMA New Zealand Decision: Application HSC09004 Page 7 of 17 Regulation2 Control Code1 Topic Variations TELair = 0.017 mg/m3 for iodomethane T2 29, 30 Controlling exposure in places of work The following WES values apply to the Ripper range: Substance (Component) Chloropicrin CAS 76-88-4 Iodomethane (methyl iodide) CAS 74-88-4 T3 5(1), 6 Requirements for keeping records of use Comments - Skin* WES (TWA) ppm Mg/m3 0.1 0.67 2 12 Regulation 6 of the Hazardous Substances (Classes 6, 8 and 9) Regulations 2001 is varied under section 77 so that the following clause is added after regulation 6(1)(g), as follows: (6) (1) (h) The size of the buffer zone, the method by which the buffer zones were calculated, and the factors taken into account when determining the buffer zones. (i) who has been notified of the intended fumigation. T4 E6 7 T5 8 T6 9 Requirements for equipment used to handle hazardous substances Requirements for protective clothing and equipment Approved handler requirements Controls T4 and E6 are combined. This control is varied under s77A as follows: The following regulation is inserted immediately after regulation 9: 9A Exception to approved handler requirements for the transportation of packaged substances within the Ripper range (1) Regulation is deemed complied with if(a) in the case of substances within the Ripper range being transported on land(i) in the case of substances within the Ripper range being transported by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with an approved safety system under section 6D of the Transport Services Licensing Act 1989 or a safety system which is referred to in an approved safety case under the Railways Act 2005; and ERMA New Zealand Decision: Application HSC09004 Page 8 of 17 Regulation2 Control Code1 Topic Variations (ii) in 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 in Schedule 1 of the Land Transport Rule 45001/1: Dangerous Goods 2005, has a current dangerous goods endorsement on his or her driver’s 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 substances within the Ripper range being transported by sea, one of the following is complied with: (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A): (ii) International Maritime Dangerous Goods Code; or (c) in the case of Ripper 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 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 handling a hazardous substance within an aerodrome; but (b) does not apply to the storage and handling of substances within the Ripper range 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 ERMA New Zealand Decision: Application HSC09004 Page 9 of 17 Regulation2 Control Code1 Topic Variations Nations.] T7 10 Restrictions on the carriage of hazardous substances on passenger service vehicles Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls E1 32-45 E2 46-48 E5 5(2), 6 Limiting exposure to ecotoxic substances Restrictions on use within application area No EEL values are set at this time and the default EELs are deleted. As no EEL is set at this time, an application rate cannot be set under this control. An application rate is proposed as an additional control under s77A (refer to end of table). Requirements for keeping records of use E7 9 Approved handler requirements Hazardous Substances (Identification) Regulations 2001 I1 6, 7, 32-35, General identification 36 (1)-(7) requirements Regulation 6 – Identification duties of suppliers Regulation 7 – Identification duties of persons in charge Regulations 32 and 33 – Accessibility of information I2 8 I3 9 I8 14 I9 18 I10 19 Regulations 34, 35, 36(1)(7) – Comprehensibility, Clarity and Durability of information Priority identifiers for corrosive substances Priority identifiers for ecotoxic substances Priority identifiers for certain toxic substances Secondary identifiers for all hazardous substances Secondary identifiers for corrosive substances ERMA New Zealand Decision: Application HSC09004 Page 10 of 17 Regulation2 Control Code1 I11 20 I16 25 I17 I18 26 27 I19 29-31 Topic Secondary identifiers for ecotoxic substances Secondary identifiers for toxic substances Use of Generic Names Use of Concentration Ranges Alternative information in certain cases Variations Regulation 29 – Substances in fixed bulk containers or bulk transport containers Regulation 30 – Substances in multiple packaging I20 36(8) I21 37-39, 4750 Regulation 31 – Alternative information when substances are imported Durability of information for class 6.1 substances Documentation required in places of work Regulation 37 – Documentation duties of suppliers Regulation 38 – Documentation duties of persons in charge of places of work Regulation 39 – General content requirements for documentation Regulation 47 – Information not included in approval Regulation 48 – Location and presentation requirements for documentation Regulation 49 – ERMA New Zealand Decision: Application HSC09004 Page 11 of 17 Regulation2 Control Code1 Topic Documentation requirements for vehicles Variations Regulation 50 – Documentation to be supplied on request I22 40 Specific documentation requirements for corrosive substances I23 41 Specific documentation requirements for ecotoxic substances I28 46 Specific documentation requirements for toxic substances I29 51-52 Duties of persons in charge of places with respect to signage I30 53 Advertising corrosive and toxic substances Hazardous Substances (Packaging) Regulations 2001 P1 5, 6, 7 (1), 8 General packaging requirements Regulation 5 – Ability to retain contents Regulation 6 – Packaging markings Regulation 7(1) – Requirements when packing hazardous substance Regulation 8 – Compatibility P3 9 P13 P15 19 21 P14 20 Regulation 9A and 9B – Large Packaging Packaging requirements for substances packed in limited quantities Packaging requirements for toxic and ecotoxic substances Packaging requirements for corrosive substances (class ERMA New Zealand Decision: Application HSC09004 Controls P13 and P15 are combined. Page 12 of 17 Regulation2 Control Code1 Topic Variations 8) PG1 Schedule 1 The tests in Schedule 1 correlate to the packaging requirements of UN Packing Group I (UN PGI). PS4 Schedule 4 This schedule describes the minimum packaging requirements that must be complied with when a substance is packaged in limited quantities Hazardous Substances (Disposal) Regulations 2001 D4 8 Disposal requirements for Controls D4 and D5 are combined. D5 9 toxic, corrosive, and ecotoxic substances D6 10 Disposal requirements for packages D7 11, 12 Disposal information requirements D8 13, 14 Disposal documentation requirements Hazardous Substances (Emergency Management) Regulations 2001 EM1 6, 7, 9-11 Level 1 emergency management information: General requirements EM2 8(a) Information requirements for corrosive substances EM6 8(e) Information requirements for toxic substances EM7 8(f) Information requirements for ecotoxic substances EM8 12-16, 18Level 2 emergency 20 management documentation requirements EM11 25-34 Level 3 emergency The trigger quantity for this control is varied to to management requirements 50L in accordance with 77(3)(a). – emergency response plans EM12 35-41 Level 3 emergency management requirements – secondary containment EM13 42 Level 3 emergency management requirements – signage Hazardous Substances (Personnel Qualification) Regulations 2001 AH1 4-6 Approved Handler requirements ERMA New Zealand Decision: Application HSC09004 Page 13 of 17 Regulation2 Control Code1 Topic Variations Hazardous Substances (Tracking) Regulations 2001 TR1 4(1), 5, 6 General tracking requirements Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 Regulations 4 to 43 The Hazardous Substances where applicable (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant. Additional controls For the purposes of this trial, Ripper 500 may be applied at rates of up to 350kg/ha. Ripper 500 shall not be applied into or onto water. Ripper 500 shall be used for pre-plant soil fumigation only. Soil fumigated with Ripper 500 as part of this trial shall be immediately covered with VIF (very impenetrable film). The sheet must remain in place for 5 days following completion of installation of the fumigant and slicing or removal of the sheet is prohibited during this time. Slicing or removal of the sheet after this 5 day period is prohibited if it is raining, or if rain is expected to fall within 48 hours. Where the removal of the impermeable plastic sheet covering fumigated soil is to take place within 14 days of the start of the installation of the fumigant, a minimum of two trained operators (i.e. appropriately licensed and trained, approved handlers) shall be present. Early re-entry by operators into the treated area (i.e. within 5 days after application of the substance) shall be permitted for the inspection and/or repair of the impermeable plastic sheet, and for flood prevention activities, only. Operators shall be wearing appropriate PPE during these activities. Access to the fumigated site without appropriate PPE shall be prohibited until the residual soil level of chloropicrin is below 0.1ppm. Ripper 500 shall not be applied within 1m of the roots of non-target plants. Installation of Ripper 500 shall be initiated no earlier than 30 minutes after sunrise and completed no later than 1 hour before sunset. For the purposes of this trial, no person may possess Ripper 500 unless that person has a licence issued under section 95B of the Act for the use of methyl bromide and chloropicrin in soil fumigation from the Authority that is obtained before the person takes possession of the substance. Use within 400 m of any sensitive site such as school, day care facility, nursing home, hospital, prison, playground, playing field, reserve or other amenity area where the public may lawfully be present shall be prohibited. For the purposes of this trial, a buffer zone of 30 m shall apply when Ripper 500 is used. A ‘buffer zone’ is an area established around the perimeter of the trial site. The buffer zone must extend from the edge of the application block equally in all directions. An ‘application block’ is a field or portion of a field treated with a fumigant in any 24-hour period. Only a person who holds a licence issued under section 95B of the Act for the use of methyl bromide and chloropicrin in soil fumigation, or who is undertaking duties in relation to the trial under the supervision of the licence holder, may be present in the buffer zone during the buffer ERMA New Zealand Decision: Application HSC09004 Page 14 of 17 Regulation2 Control Code1 Topic Variations zone period. All other persons including field workers, nearby residents, pedestrians, and other bystanders, must be excluded from the buffer zone during the buffer zone period except for transit (see next bullet). The ‘buffer zone period’ starts at the moment when any fumigant is delivered/dispensed to the soil within the trial site and lasts for a minimum of 48 hours after the fumigant has stopped being delivered/dispensed to the soil. No fumigant applications will be permitted within 400 metres of any school, day care facility, nursing home, assisted living facility, elder care facility, hospitals, in-patient clinic, prison, or playground. Bus stops or other locations where persons wait for public transport are not permitted within the buffer zone. Buffer zones may not include buildings used for storage such as sheds, barns, garages, etc., UNLESS: the storage buildings are not occupied during the buffer zone period; and the storage buildings do not share a common wall with an occupied structure. Buffer zones may not include residential areas (including employee housing, private property, buildings, commercial, industrial, and other areas that people may occupy or outdoor residential areas, such as lawns, gardens, or play areas). Buffer zones may not include agricultural areas owned/operated by persons other than the owner/operator of the application block, UNLESS: the owner/operator of the application block can ensure that the buffer zone will not overlap with a buffer zone from any adjacent property owners; and the owner/operator of the areas that are not under the control of the application provides written agreement to the applicator that they, their employees, and other persons will stay out of the buffer zone during the entire buffer zone period. Buffer zones may not include publicly owned and/or operated areas (e.g., parks, rights of way, foot paths, walking paths, playgrounds, athletic fields, etc), UNLESS: the area is not occupied during the buffer zone period; and the owner/operator of the application block has taken every reasonable step or precaution to ensure that entry by non-handlers is prohibited during the buffer zone period. The person in charge of this trial shall be responsible for establishing the buffer zone and ensuring that workers or bystanders do not enter the buffer zone for 48 hours following the completion of the trial. Notification of intended fumigation The person in charge of this trial must notify every person who may be affected by the fumigation, of their intention to carry out fumigation. Signage (1) A person who carries out a fumigation using Ripper 500 for the purposes of this trial must erect ERMA New Zealand Decision: Application HSC09004 Page 15 of 17 Regulation2 Control Code1 Topic Variations signs around the perimeter of the buffer zone at potential points of entry. Signs must be posted from the start of installation of the fumigant until 48 hours following the completion of the trial. (2) Signs must be erected at every point of access to the place where fumigation will be carried out that – a. State that fumigation is being carried out; and b. Identify the hazardous substance being used and state that it is toxic to humans; and c. Describe the general type of hazard associated with the substance. (3) Signs erected in accordance with subclause (2) must – a. Comply with regulation 34(1), (2), and (4) and regulation 35(1), (3), and (5) of the Hazardous Substances (Identification) Regulations 2001, but as if the distances referred to in regulation 35(3) were a distance of not less than 10 metres; and b. Identify the person in charge of the trail and provide sufficient information to enable the person to be contacted during normal business hours; and c. State the day on which the trial commenced; and d. State the actions that must be taken in an emergency. (4) Signs must be removed within 3 days of the completion of the installation of the fumigant in accordance with the control below relating to the notice of completion of the trial. The trial site boundaries shall be clearly marked and distinctly visible from outside the trial site throughout the life of the trials. Completion of the trial and notice of completion (1) The trial is complete when the impermeable plastic sheet covering the fumigated soil is removed, in accordance with the controls which govern this activity. (2) When fumigation is complete, the person carrying out the fumigation must give notice that fumigation is complete to each person to whom notice was given in accordance with the control describing requirements for the “Notification of intended fumigation”. Plastic sheets used to cover fumigated soil must be disposed of as hazardous waste. Installation of the fumigant must be initiated and completed within 1 (24 hour) day during the period of time covered by this approval. No produce grown in the trial area shall be consumed by people or (so far as is reasonably practicable) animals or sold, offered for sale, given away, bartered or otherwise distributed unless the ACVM Group has approved this process as part of a provisional registration or research permit. ERMA New Zealand Decision: Application HSC09004 Page 16 of 17 APPENDIX 2: LEGISLATIVE CRITERIA FOR THE APPROVAL A2.1 Unless otherwise stated, references to section numbers in this decision refer to sections of the Act and references to clauses refer to clauses in the Methodology A2.2 The application was lodged pursuant to section 31. The decision was made in accordance with section 32, taking into account additional matters to be considered in that section and matters specified under Part II of the Act (including the Methodology) and the provisions of Part III of the Third Schedule of the Act. A2.3 Government departments with an interest in this type of application were advised of the receipt of the application in accordance with clause 2(2)(e). A2.4 This application was considered by the Chief Executive of ERMA New Zealand under delegation from the Authority (section 19(2)(e)). A2.5 In accordance with section 32, the approach adopted when considering this application was to confirm whether the application was for one of the purposes specified in section 30, to identify and assess the risks (Clauses 9, 12, 13, 14, 22, 24, 25) and to determine whether the substance could be adequately contained by controls to provide for each of the matters specified in Part III of the Third Schedule of the Act. A2.6 In accordance with clause 36(2)(b), it is recorded that, in reaching his decision, the Chief Executive applied the criteria specified in section 32. A2.7 The Chief Executive also applied the following criteria in the Methodology: clause 11 – characteristics of substance; clause 21 – the decision accords with the requirements of the Act and regulations; clause 26 – all risks negligible; clause 35 – the costs and benefits of the controls. ERMA New Zealand Decision: Application HSC09004 Page 17 of 17