Application Code
Application Type
Applicant
Purpose of the Application
HSC05019
To import or manufacture hazardous substances in containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Syngenta Crop Protection Limited
Tower 2, Level 7
110 Symonds Street
Auckland
To import into containment fungicidal compounds of the chemical class of Heteroaromatic Amides (ARYAM) for use in small-scale contained field trials to provide information for development of these compounds
Date Application Received
Consideration Date
14 July 2005
25 August 2005
Considered by Rob Forlong, Chief Executive of ERMA New Zealand
1.1
The application to import into containment the hazardous substances ARYAM 1 and
ARYAM 2 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 identifiers for the ERMA New
Zealand Hazardous Substances Register:
ARYAM 1
ARYAM 2
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 HNSO 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
3.1
3.2
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.
The application was formally received on 14 July 2005.
Project Team:
Amanda McKenzie Applications Advisor (Hazardous Substances)
Sue Scobie
Peter Jackson
Report review and sign-out by:
Senior Science Advisor (Hazardous Substances)
Advisor (Māori Unit)
Noel McCardle Applications Team Leader (Hazardous
Substances)
3.3
3.4
The applicant supplied the following documents:

The application

Confidential appendices.
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
A response was received from the Ministry of Health stating that “with appropriate
HSNO controls, the Ministry has no issues to raise at this time relating to the acceptance of this application based on non-confidential information provided from a public health perspective (non-occupational)”.
3.6
The applicant was provided with a copy of the proposed controls for ARYAM 1-2 and given the opportunity to comment on them. The comments received from the applicant were taken into account when considering this application.
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).
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4.2
In accordance with section 32 of the Act, 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 and to determine whether the substances could be adequately contained by controls to provide for each of the matters specified in Part III of the Third Schedule of the Act.
Purpose of the Application
4.3
The purpose of the application is to import into containment fungicidal compounds of the chemical class of Heteroaromatic Amides (ARYAM) for use in small-scale contained field trials to provide information for development of these compounds
4.4
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 Act.
Life Cycle
4.5
Syngenta Crop Protection Ltd plans to import up to 2.5 litres each of ARYAM 1 and
ARYAM 2 (up to 5 litres total) over a period of five years. They will be stored by
Syngenta Crop Protection Ltd and will be dispensed into spray mix quantities prior to transporting to the trial site, where the spray mixtures will be prepared and applied.
Disposal procedures for surplus samples, spray mixtures and used containers are detailed in the Management Plan supplied by the applicant.
Hazardous Properties
4.6
I note that a containment application requires only sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls.
4.7
The applicant has assessed the available information, which is limited, and has noted that there is insufficient data on the substances ARYAM 1-2 to identify whether any hazard thresholds are exceeded. I note that the applicant has focussed on the active component in their assessment of hazardous properties.
4.8
I note that there is limited information available on the substances. However, I have assumed that the substances have both toxic and ecotoxic hazards and consider that the information is sufficient for me to determine whether any risks can be managed by the containment controls.
Identification and Evaluation of the Significant Risks of the Substances in
Containment
4.9
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential risks of escape from containment under the headings of environmental, human health and welfare and Māori issues and concerns.
4.10
In the application, the applicant identified and assessed potential risks, and detailed proposals for, and impacts of risk management. I have reviewed the applicant’s assessment of the risks and agree that it is suitable for the consideration below.
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Risks to the Environment
4.11
If released off target, the substances have the potential to cause adverse effects on the environment.
4.12
On the basis of the lifecycle of the substances outlined in paragraph 4.5, 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 Management Plan

Failure to follow the correct operational procedures as set out in the controls, resulting in release of the substances.
4.13
I consider that, taking into account the properties of the substances, the quantity 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
4.14
Although there is limited information on the substances, I consider that the substances have potential to cause adverse effects on human health.
4.15
On the basis of the lifecycle of the substances outlined in paragraph 4.5, 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 Management Plan

Failure to follow the correct operational procedures as set out in the controls, resulting in release of the substances.
4.16
I consider that, taking into account the properties of the substances, the quantity 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 onerous to be complied with and therefore the risks to human health and welfare are negligible.
Māori issues and concerns
4.17
I have considered the potential Māori cultural effects of this application in accordance with the Methodology clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO
Act, and the assessment framework contained in the ERMA New Zealand User Guide
“Working with Māori under the HSNO Act 1996”.
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4.18
I note that the 2 Heteroaromatic Amides may have hazardous properties that trigger
HSNO toxicity and ecotoxicity thresholds. There is the potential for these substances to have a negative impact on Māori and the mauri of iwi, cultural tāonga and the environment.
4.19
I am unaware of any impacts that the 2 Heteroaromatic Amides could have on Māori culture, or, on traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. I have no evidence to suggest that the controlled containment-trial use of the 2 Heteroaromatic Amides will breach the principles of the Treaty of Waitangi and see no requirement for the applicant to consult with Māori regarding this application.
4.20
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 suggested that the appropriate authorities are notified 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 10)

To exclude organisms from a facility (for example, control 7)

To exclude unauthorized people from the facility (for example, control 6)

To prevent unintended release of the substances by experimenters working with the substances (for example, control 9)

To control the effects of any accidental release of the substances (for example, control 19)

Inspection and monitoring requirements (for example, control 24)

Qualifications required of the person responsible for implementing the controls (for example, control 13).
5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, ARYAM 1 and ARYAM 2 can be adequately contained.
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6.1
I have considered this application made under section 31, and pursuant to section 32, I am satisfied that this application is for a purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of ARYAM 1 and ARYAM 2,
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 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 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 ARYAM 1 and
ARYAM 2 is thus approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
26 August 2005
Rob Forlong Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
ARYAM 1: HSC000205
ARYAM 2: HSC000206
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1.
The trials shall be undertaken in accordance with the Management Plan which accompanied the application. Modifications of the Management Plan may be approved in writing by ERMA New Zealand providing that they comply with the following controls.
2.
Notwithstanding the requirements of control 1 above, the trials shall also comply with the following controls:
3.
The trials may be carried out at a location that is not defined until an infestation of the target pest has been found, only if the applicant;
has permission from the owner of the land to carry out the trial; and
notifies ERMA New Zealand of the locations as per control 22.
4.
The trial sites shall be chosen so as to prevent the substances entering any surface water or groundwater system.
5.
The trial sites shall be located to prevent any building where people live or work being exposed to the substances.
6.
Access to the trial sites shall be by permission of the Trial Director 1 or owner of the property on which it is located. The trial site boundaries shall be clearly marked and distinctly visible from outside the trial site throughout the life of the trials. The trial sites shall be signed indicating that unauthorized access is not allowed, that the site is subject to a trial, and that the crops should not be removed or disturbed.
7.
In any location where it is possible for grazing animals to access the trial site, the trial sites shall be secured by stock proof fencing to exclude grazing animals for the duration of the trial.
8.
The substances shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS8409: 2004.
9.
The substances shall be mixed, diluted and prepared in any other way prior to application in accordance with the relevant sections of the Code of Practice for the Management of
Agrichemicals NZS8409: 2004.
10.
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.
11.
The substances shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005.
1 The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the trial in accordance with the Management Plan and approval controls.
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12.
The substances shall be applied by way of hand-held/operator-worn equipment, using hydraulic pressure or compressed CO
2
or air on plots specifically designated and marked for each treatment, in accordance with the Code of Practice for the Management of
Agrichemicals NZS8409: 2004. 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 of the trial site.
13.
The personnel applying the substances to the crops shall be able to demonstrate that they have the qualifications necessary to carry out the trial. Ways of demonstrating this would include the holding of an appropriate Growsafe certification or an Approved Handler qualification. They should also be aware of the Management Plan and the controls in place in order to adequately manage the substances.
14.
No sprayed produce shall be consumed by people or animals or offered for sale.
15.
Sprayed produce shall be disposed of by ploughing in, by mulching or by burial at an approved landfill (not to be diverted to any composting operation). Sprayed produce may also be desiccated and left to decay in the field where it will be ploughed in.
16.
The amount of spray prepared shall be adequate for the trial site, but if there is any surplus spray mix it shall be disposed of within the trial site by being further diluted and sprayed over a marked and designated non-crop and non-grazed area at the site.
17.
Any equipment used shall be rinsed after use with the appropriate detergent or decontaminant, and rinsate disposed of within the trial site by being sprayed over a marked and designated non-crop and non-grazed area at the site.
18.
Surplus substances remaining at the end of the trials shall be returned to Syngenta Crop
Protection Ltd for secure storage in an exempt laboratory, exported or degraded to nonhazardous substances (note that once the trials are complete the substances do not have approval to be present in New Zealand except in an exempt laboratory).
19.
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.
20.
A record shall be kept of all use of the substances. This record shall cover all matters referred to in Regulation 6 of the Hazardous Substances (Classes 6, 8 and 9 Controls)
Regulations 2001.
21.
Information on appropriate safety precautions necessary to provide safeguards against the substances’ toxic and ecotoxic properties shall accompany the substances at all stages of its lifecycle. Personal protective equipment shall be worn when handling the substances during the use stage of the lifecycle.
22.
The Department of Labour [Attn. HSNO Project Manager (Workplace Group) or equivalent position] and ERMA New Zealand shall be informed in writing (by letter, fax
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or email) of the location, start, and completion of the trials. Notifications shall include the following details:
Substance names
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
ARYAM 1
ARYAM 2
HSC05019
HSC000205
HSC000206
Amanda McKenzie
23.
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. It is suggested that if a breach in containment results in contamination of a waterway, the relevant iwi authorities be advised.
24.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time.
25.
This approval remains in place for the term of any concurrent approval required under the
Agricultural Compounds and Veterinary Medicines Act 1997, to a maximum of five years.
26.
The maximum total quantity of ARYAM 1 and ARYAM 2 that shall be imported under this approval is 2.5 Litres of each substance.
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