12 May 2006
Application Code
Application Type
HSC06005
To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Purpose of the Application
Syngenta Crop Protection Limited
To import under containment experimental plant protection compounds for the purpose of testing for the control of weeds, plant damaging organisms or the management of crop plants in various agricultural, horticultural and forestry crops (field trial)
29 March 2006 Date Application Received
Consideration Date 12 May 2006
Considered by Rob Forlong, Chief Executive of ERMA New Zealand
1.1
The application to import into containment the hazardous substances, Experimental
Plant Protection Compounds, is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the
HSNO Act) and the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substances have been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
Experimental Plant Protection Compounds
(HSC06005)
2.1
The application was lodged pursuant to section 31 of the HSNO Act. The decision was determined in accordance with section 32, taking into account additional matters to be considered in that section and matters relevant to the purpose of the HSNO Act, as specified under Part II of the HSNO Act and the provisions of Part III of the Third

Schedule of the HSNO Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the HSNO 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.
3.1
The application was formally received on 29 March 2006.
3.2
Project Team:
Beth Dye
Sue Scobie
Peter Jackson
Applications Manager (Hazardous Substances)
Senior Science Adviser (Hazardous Substances)
Advisor, Maori Unit
Report review and sign-out by:
Noel McCardle Applications Team Leader (Hazardous
Substances)
3.3
3.4
The applicant supplied the following documents:

The application, including a confidential appendix containing the proposed containment system.
The following Government departments were advised of the receipt of the application
(in accordance with clause 2(2)(e)) and given the opportunity to comment:

The Ministry of Health;

The Department of Labour (Workplace Group);

The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
3.6
No responses were received.
The applicant was provided with a copy of the proposed controls for Experimental
Plant Protection Compounds and given the opportunity to comment on them. The comments provided were taken into account in the setting of controls.
Sequence of the Consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e) of the HSNO Act).
4.2
In accordance with section 32 of the HSNO Act, the approach adopted when considering this application was to confirm whether the application was for one of the
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purposes specified in section 30, to identify and assess the risks 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 HSNO Act.
Purpose of the Application
4.3
The purpose of the application as defined by the applicant is to import under containment experimental plant protection compounds for the purpose of testing for the control of weeds, plant damaging organisms or the management of crop plants in various agricultural, horticultural and forestry crops.
4.4
The application has been submitted to cover import or manufacture of experimental pesticides for routine field trials, with the intention that under this approval these will in future require notification to ERMA New Zealand prior to the field trial rather than a new application each time.
4.5
As the purpose amounts to “research and development on any hazardous substance”, I consider that the application qualifies for consideration under section 30(ba) of the
HSNO Act.
Life Cycle
4.6
Syngenta Crop Protection Ltd plans to import a maximum of 100 litres (or 100 kg) of each experimental plant protection compound over the course of the total evaluation period, normally at the rate of less than or equal to 20 litres (or 20kg) per season. The applicant states that each substance will be imported fully packaged, with the substance contained in a polyethylene terephthalate (PET) bottle or other suitable container, surrounded by inner absorbent material and outer packaging. It will be transported in this state to a storage facility.
4.7
It will be dispensed into spray mix quantities prior to transporting to the trial site, where the spray mixture will be prepared and applied.
4.8
Appropriate disposal procedures for surplus sample and spray mixture are detailed in the containment system supplied by the applicant as part of the application.
Hazardous Properties
4.9
I note that a containment application only requires sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls.
4.10
The applicant states that all the substances that will be covered by this application are likely to be hazardous. However, the scope of the hazard information will often be limited, as the substances will be experimental and may not be commercialised. Each substance imported or manufactured under this approval will be notified to ERMA New
Zealand prior to its use, and the notification will include compositional information, a
Project Plan and a Safety Data Sheet and / or any available hazard information.
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4.11
I have taken this into account in my review of the substances’ hazardous properties, and consider that the information is sufficient for me to determine that any risks can be managed by the containment controls.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.12
The applicant has identified and assessed potential risks and detailed proposals for, and impacts of, risk management. I have reviewed the applicant’s assessment of the risks to the environment, human health and welfare and Maori issues and concerns as set out below:
Risks to the Environment
4.13
If released off target, the substances have the potential to result in adverse effects on the environment.
4.14
On the basis of the lifecycle of the substances outlined in paragraphs 4.6-4.8, adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substances;
 failure to follow correct disposal procedures as outlined in the containment system; or
 failure to follow the correct operational procedures as set out in the controls, resulting in release of the substances.
4.15
I consider that, taking into account the properties of the substances, the quantities involved, the containment regime proposed by the applicant, the containment controls in Appendix 1 and controls in place under other legislation, there are no significant risks to the environment. I consider that the controls in place are not too onerous to be complied with and therefore the risks to the environment are negligible.
Risks to Human Health and Welfare
4.16
If the substances are ingested or inhaled, or come in contact with skin or eyes they have the potential to cause adverse effects on human health.
4.17
On the basis of the lifecycle of the substances outlined in paragraph 4.6-4.8, adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substances;
 failure to follow correct disposal procedures as outlined in the containment system; or
 failure to follow the correct operational procedures as set out in the controls, resulting in release of the substances.
4.18
I consider that, taking into account the properties of the substances, the quantities involved, the containment regime proposed by the applicant, the containment controls in Appendix 1 and controls in place under other legislation, there are no significant risks to human health and welfare. I consider that the controls in place are not too
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onerous to be complied with and therefore the risks to human health and welfare are negligible.
Māori issues and concerns
4.19
I have considered the potential Māori cultural effects in accordance with the
Methodology clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO Act. In addition, I have used the assessment framework contained in the ERMA New Zealand
User Guide “Working with Māori under the HSNO Act 1996” in assessing this application.
4.20
I have noted that Experimental Plant Protection Compounds will have hazardous properties that trigger several HSNO toxicity and ecotoxicity thresholds. There is the potential that these substances could have a negative impact on Māori and the mauri of iwi, cultural tāonga and the environment.
4.21
Having regard to the risks associated with these substances, I do not consider they will have any significant impact on Māori culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. I have no evidence to suggest that the use of Experimental Plant Protection Compounds in containment will breach the principles of the Treaty of Waitangi and see no requirement for the applicant to consult with Māori regarding this application.
4.22
This assessment is made on the condition that the substances are handled, blended, stored, transported, used and disposed of, in accordance with the explicitly stated controls, and any controls stipulated in other applicable Acts. However, should inappropriate use, or an accident, result in the contamination of waterways or the environment, it is recommended that the Trial Director notify the appropriate authorities including the relevant iwi authorities in that region. This action should include advising them of the contamination and the measures taken to contain and remedy it.
5.1
I have evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and note 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 (for example, control 11);
 to exclude organisms from a facility (for example, control 9);
 to exclude unauthorized people from the facility (for example, control 8);
 to prevent unintended release of the substances by experimenters working with the substance (for example, control 10);
 to control the effects of any accidental release of the substance (for example, control
20);
 inspection and monitoring requirements (for example, control 25); and
 qualifications required of the person responsible for implementing the controls (for example, control 14).
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5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, Experimental Plant Protection Compounds can be adequately contained.
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 purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of Experimental Plant
Protection Compounds, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substances being adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology I record that, in reaching this conclusion, I have applied the criteria specified in section 32 of the HSNO Act.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substances;
 clause 21 – the decision accords with the requirements of the HSNO Act and regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques.
6.5
The application to import into containment the hazardous substances Experimental
Plant Protection Compounds is thus approved pursuant to section 32 of the HSNO Act, with controls as set out in Appendix 1.
Rob Forlong Date 12 May 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Experimental Plant Protection Compounds: HSC000232
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1.
Each substance imported or manufactured under this approval shall be notified in writing to ERMA New Zealand prior to its use in a field trial. The notification shall include:
a unique identifier for the substance;
composition details;
a Project Plan for the trials, containing information as specified in
Appendix 2;
a Safety Data Sheet and/or any known hazard information; and
the following identifying details:
ERMA Application number HSC06005
ERMA Approval number
ERMA Applications Advisor
HSC000232
Beth Dye
2.
This approval will not apply to substances which trigger any hazardous property thresholds in classes 1, 2, 3.2, 4 or 5.
3.
This approval applies only to the ground-based application of plant protection compounds to agricultural and horticultural crops, to forestry and pastures, and to seeds. This approval excludes any application of substances direct to water and any aerial application of substances.
4.
The trials shall be undertaken in accordance with the Containment System which accompanied the application, and the Project Plan which accompanies the notification of the substance. Modifications to the Project Plan or Containment System may only be made with the prior written approval of ERMA New Zealand.
5.
The trials may be carried out at a location that is not defined until an infestation of the target pest has been found, provided the applicant:
has written permission from the owner of the land to carry out the trial; and
notifies ERMA New Zealand in writing of the location in accordance with Control [23].
6.
The trial sites shall be chosen so as to prevent the substances entering any surface water or groundwater system.
7.
The trial sites shall be located to prevent any residential building or workplace which is not related to the research from being exposed to the substance.
8.
Access to the trial sites shall be by permission of the Trial Director 1 , or owner or occupier of the property on which it is located. The trial site boundaries shall be clearly marked and distinctly visible throughout the life of the trials. The trial site shall be signed
1 The Trial Director is the individual appointed by the applicant, and named in the Project Plan as being responsible for the overall conduct of the trial in accordance with the Management Plan and approval controls.
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indicating that unauthorized access is not allowed, that the site is subject to an experimental pesticide trial, and that the crops should not be removed or disturbed.
9.
Trial sites that are at risk of entry by grazing animals shall be secured by stock proof fencing to exclude animals for the duration of the trial. In these situations, stock proof fencing is not required if a stock withholding period set by the ACVM Group of the New
Zealand Food Safety Authority has elapsed.
10.
The substances shall be stored, mixed, diluted and prepared in any other way prior to application in accordance with good practice. This may be demonstrated by compliance with the Code of Practice for the Management of Agrichemicals NZS8409:2004 or a
Standard Operating Procedure retained as part of the applicant’s trial records.
11.
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in accordance with the Hazardous Substances (Identification) Regulations 2001. A Safety Data Sheet shall accompany each shipment.
12.
The substances shall be transported in accordance with good practice and where appropriate in compliance with the Land Transport Rule: Dangerous Goods 2005.
13.
The substances applied to agricultural and horticultural crops, to forestry and to pastures shall be applied by way of equipment calibrated to apply accurate doses to trial plots on plots specifically designated and marked for each treatment, in accordance with good practice. This would generally be achieved through compliance with the Code of Practice for the Management of Agrichemicals NZS8409:2004 or a Standard Operating Procedure retained as part of the applicant’s trial records. Special attention shall be paid to the minimisation of spray drift, and in particular to the avoidance of drift beyond boundaries agreed with the owner or occupier of the trial site and delineated in accordance with
Control [8].
Seed treatment applications shall be made following the Project Plan and using suitable seed treatment apparatus. Treated seed shall be sown in a manner likely to minimise exposure to birds. Where this is not possible, birds shall be actively deterred from foraging on the trial site.
14.
The personnel applying the substances to the crops shall be able to demonstrate that they have the qualifications necessary to carry out the trial, for example, by holding appropriate Growsafe certification or an Approved Handler qualification. They should also be aware of the contents and requirements of the containment system and these controls in order to adequately manage the substances.
15.
No sprayed produce 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.
16.
Sprayed produce that may be at risk of being removed from the trial after its completion shall be disposed of by ploughing in, by mulching or by burial on the trial site or at an approved landfill. The Trial Director shall decide the method of disposal after assessing the relevant risks. Sprayed produce must not be diverted to any composting operation.
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17.
The amount of spray prepared shall be the minimum necessary for the trial, but if there is any surplus spray mix it shall be disposed of within the trial site by spraying over a marked and designated non-crop and non-grazed area at the site, or alternatively within the trial plot.
18.
Any equipment used shall be triple rinsed after use with water and if required with an appropriate detergent or decontaminant, and the rinsate disposed of within the trial site by being sprayed over a marked and designated non-crop and non-grazed area at the site, or alternatively within the trial plot.
19.
Surplus substances remaining at completion of the trials shall be returned to Syngenta
Crop Protection Ltd in original containers for secure storage in an exempt laboratory, exported from New Zealand or disposed of by destruction through a commercial chemical processor. (Completion is defined as the end of the trial programme as specified in the
Project Plan for each substance. Once the trials are complete the substances do not have approval to be present in New Zealand except in an exempt laboratory).
20.
Any accidental spillage of the unmixed substances or spray mix shall be contained, prevented from entering waterways, and absorbed with an appropriate absorbent material.
This material shall be placed into sealed containers and disposed of at an appropriate waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance policy.
21.
A record shall be kept of all use of the substances. This record shall cover all matters referred to in Regulation 6(1) of the Hazardous Substances (Class 6, 8 and 9 Controls)
Regulations 2001 and must be kept for not less than 3 years after the date on which the substance that the record relates to is applied or discharged.
22.
Information on appropriate safety precautions necessary to provide safeguards against the substances’ toxic and ecotoxic properties shall accompany the substances at all stages of their lifecycles. Safety glasses, gloves and protective clothing shall be worn when handling the substances throughout their lifecycles.
23.
The Department of Labour [Attn. HSNO Project Manager (Workplace Group) P O Box
3705, Wellington] and ERMA New Zealand shall be informed in writing (by letter, fax or email) of the location, start, and completion of the trials. Notifications shall include the following details:
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
HSC06005
HSC000232
Beth Dye
24.
If for any reason a breach of containment occurs, the Trial Director shall notify the
Department of Labour and ERMA New Zealand within 24 hours of the breach being detected. If a breach in containment results in contamination of a waterway, it is recommended that the relevant iwi authorities be advised.
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25.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time.
26.
This approval remains in force for five years from the date of this Decision.
27.
The maximum total quantity of each experimental plant protection compound that shall be imported under this approval is 100 litres or 100 kg.
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The Project Plan to be supplied for each substance shall contain information on the following points:
1) Direction, including identification of the Trial Director
2) Substance
3) Project title
4) Objectives
5) Locations
6) Plot size
7) Total treated area
8) Application method
9) Application period
10) Application rate
11) Protection of bees
12) For treated seeds, how risks to birds will be addressed
13) Disposal of treated produce
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