ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
6 October 2003
Application Code
HSC03011
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Syngenta Crop Protection Limited
Purpose of the Application
To import into containment the substance NZF2 to
conduct small scale field trials to evaluate whether the
substance is suitable for use in New Zealand agriculture
and horticulture and to provide data for a future
application for approval for release.
Date Application Received
28 August 2003
Consideration Date
6 October 2003
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import or manufacture NZF2 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.
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
NZF2
2
Legislative Criteria for Application
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 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.
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2.2
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology). Unless
otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3
Application Process
3.1
The application was formally received on 28 August 2003 and verified as having
sufficient information on the same day.
3.2
The Project Team consisted of Susan Robertson (Applications Advisor) and Peter
Dawson (Senior Scientific Advisor).
3.3
The applicant supplied the following documents which included information identified
as confidential:
 The application;
 Formulation details (confidential appendix);
 Chemical and physical properties of NZF2 (confidential appendix);
 Material Safety Data Sheet for a similar substance (confidential appendix);
 Summary of hazardous properties and threshold data for the substance (confidential
appendix);
 Intended use of the substance (confidential appendix); and
 Proposed containment regime (confidential appendix).
3.4
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;
 ACVM Group of NZFSA;
 The Department of Labour (Occupational Safety and Health).
3.5
The Ministry of Health responded that, with appropriate controls, it has no issues to
raise at this time relating to the acceptance of this application based on the nonconfidential information provided from a public health perspective (non-occupational).
3.6
The NZFSA responded that the application would be considered under the ACVM Act,
and any issues which may arise under the Acts administered by MAF and NZFSA
would be considered as part of its application process.
3.7
The ERMA New Zealand Senior Advisor (Māori Affairs) was advised of the
application. Her comments form the basis of paragraphs 4.20 and 4.21 of this decision.
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4
Consideration
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 Act, the approach adopted when considering this
application was to confirm whether the application has fulfilled one of the 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 Act.
Purpose of the Application
4.3
The purpose of the application is to import the substance NZF2 into containment, so
that small scale field trials can be carried out to determine if the substance is suitable for
use in New Zealand and to provide data for a future application for approval for release
and registration under the ACVM Act.
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.
Hazard Properties
4.5
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.
4.6
The known hazardous properties of the substance and individual components, and
confidential information relating to the composition of the substance, were provided by
the applicant. Given its stage of development, there are some gaps in the toxicity data
for NZF2, however the applicant has advised that all ingredients in NZF2 are currently
used in New Zealand.
4.7
The applicant has assessed the hazardous properties for NZF2 and has identified that the
hazard properties of this substance are its physical (flammability), toxic (acute oral and
dermal toxicity), irritant (dermal and ocular) and ecotoxic (aquatic and terrestrial
vertebrate toxicity) properties.
4.8
I have reviewed the applicant’s hazard information and consider that it is sufficient to
describe the hazards associated with NZF2 to ensure that any risks can be managed by
the containment controls.
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Life cycle
4.9
Syngenta Crop Protection Limited plans to import up to 5 litres of NZF2, fully
formulated and packaged, into New Zealand. The applicant advised that it will be
stored by Syngenta Crop Protection Limited, before being transported to the researchers
conducting the trials. Trained personnel will dispense and mix the spray which will be
applied to crops on private properties or commercial enterprises in order to obtain data
for future regulatory approvals.
4.10
The applicant advised that any surplus substance will be disposed of by being returned
to Syngenta for re-use in other trials, by export from New Zealand, by disposal in an
appropriate local authority landfill (pre-treatment at a hazardous waste facility may be
required), or by dilution with water followed by spreading over a designated non-crop,
non-grazed waste area at the trial sites. The applicant also advised that, when registered
under the ACVM Act and approved by ERMA New Zealand, the product may be given
to a commercial grower to use. Refer to paragraph 5.2 and control 17 (Appendix 1).
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
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.
4.12
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 risks and agree that it is suitable for the consideration below.
Risks to the Environment
4.13
The applicant has identified that exposure to the substance has the potential to result in
adverse effects on aquatic organisms, if released into waterways. It also has the
potential to result in adverse effects on terrestrial vertebrates that become exposed to the
substance.
4.14
Taking into account the lifecycle of the substance outlined in paragraphs 4.9 to 4.10,
adverse effects to terrestrial vertebrates or aquatic organisms could arise from:
 An accident during storage, dispensing, mixing, use or transportation, resulting in
exposure to the substance or release of the substance into the environment
(including waterways);
 Failure to follow instructions detailed on the labelling (including Material Safety
Data Sheets), the trial protocol or this approval during any stage of the substance’s
lifecycle;
 Removal by unauthorised visitors or animals accessing the trial site (for example,
dogs, cats, rodents, birds);
 Spray-drift during application, resulting in animals consuming exposed produce
from non-trial facilities or otherwise being exposed to the substance, or resulting in
the substance entering waterways;
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
Removal of the product from the trial site by water, air or carried on workers’
clothing.
4.15
The applicant has identified that the substance has the potential to result in adverse
effects on the environment through its flammability. Taking into account the lifecycle
of the substance outlined in paragraphs 4.9 to 4.10, this could arise from:
 An accident during storage, dispensing, mixing, use or transportation, with exposure
to an ignition source;
 Failure to follow instructions detailed on the labelling (including Material Safety
Data Sheets), the trial protocol or this approval during any stage of the substance’s
lifecycle, with exposure to an ignition source.
4.16
I consider that, taking into account the properties of the substance, the quantity involved
and the containment controls in Appendix 1, and controls in place under other
legislation, there are no significant risks to the environment.
Risks to Human Health and Welfare
4.17
The applicant has identified that oral, dermal or ocular exposure to NZF2 could result in
adverse effects on human health and welfare, through its acute toxicity and irritating
properties.
4.18
Taking into account the lifecycle of the substance outlined in paragraphs 4.9 to 4.10,
adverse effects from NZF2 could arise from:
 An accident during storage, dispensing, mixing, use or transportation, resulting in
exposure to the substance;
 Failure to follow instructions detailed on the labelling (including Material Safety
Data Sheets), the trial protocol or this approval during any stage of the substance’s
lifecycle;
 Exposure to unauthorised visitors to the trial sites;
 Spray-drift during application, resulting in consumption of exposed produce from
non-trial facilities or people otherwise being exposed to the substance.
4.19
I consider that, taking into account the properties of the substance, the quantity involved
and the controls in Appendix 1 and controls in place under other legislation, there are no
significant risks to human health and welfare.
Māori issues and concerns
4.20
I have considered the potential Māori cultural effects of this application in accordance
with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework
contained in the ERMA New Zealand User Guide “Working with Māori under the
HSNO Act 1996”.
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4.21
On the basis of the information provided by the ERMA New Zealand Senior Advisor
(Māori Affairs), I consider that the substance is unlikely to have an impact on the
relationship of Māori and their culture and traditions with their ancestral lands, water,
sites, waahi tapu, valued flora and fauna and other taonga, and that there is no
requirement to consult with Māori regarding this application. This is on the condition
that the substance is used in accordance with the controls in Appendix 1, and in
accordance with any other relevant controls applied under other legislation.
5
Containment and Controls
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;
 To exclude organisms from a facility;
 To exclude unauthorized people from the facility;
 To prevent unintended release of the substance by experimenters working with the
substance;
 To control the effects of any accidental release of the substance;
 Inspection and monitoring requirements;
 Qualifications required of the person responsible for implementing the controls.
5.2
With respect to the applicant’s intended disposal of surplus NZF2, I advise that NZF2
cannot be disposed of in a landfill or used by non-approved commercial or research
facilities or in any manner contrary to this approval. Surplus NZF2 shall therefore be
returned to Syngenta Crop Protection Limited for secure storage in an exempt
laboratory, exported or degraded to a non-hazardous substance. Note that once the trials
are complete the substance does not have an approval to be present in New Zealand
except in an exempt laboratory. Refer to paragraph 4.10.
5.3
I am satisfied that with adherence to the controls listed in Appendix 1 and those controls
in place under other legislation, NZF2 can be adequately contained.
6
Decision
6.1
I have considered this application under section 31 to import the hazardous substance
NZF2 into containment, and pursuant to section 32, I am satisfied that this application is
for the purpose specified in section 30(ba).
6.2
I have considered the risks associated with the lifecycle of NZF2 and I am satisfied that
the controls imposed, including those in place under other legislation, will result in the
substance 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.
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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 substance NZF2 is thus
approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC03011
HSC000065
Page 7 of 10
Appendix 1: List of controls that apply to the
hazardous substance NZF2
1. The trials shall be undertaken in accordance with the information contained within the
applicant’s application and field protocol.
2. Notwithstanding the requirements of control 1 above, the trials shall comply with
controls 3 to 23 below.
3. The maximum quantity of NZF2 that shall be imported is 5 litres.
4. The trials may be carried out at a location that is not defined, provided the applicant;
i.
has permission from the owner of the land to carry out the trial.
ii. notifies ERMA New Zealand of the locations as per control 21.
5. The trial sites shall be chosen so as to prevent any of the substance entering any surface
water or groundwater system.
6. The trial sites shall be located to prevent any building where people live or work being
exposed to the substance.
7. Access to the trial sites shall be by permission of the Trial Director1 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 primary
access points 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.
8. The substance shall be stored in accordance with good practice. This would generally be
achieved through compliance with the Code of Practice for the Management of
Agrichemicals NZS8409.
9. The substance shall be securely packed and stored 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.
10. The substance shall be transported in accordance with good practice. This may require
compliance with The Land Transport Rule: Dangerous Goods 1999.
11. The substance shall be applied by way of hand-held/operator-worn equipment, using
hydraulic pressure or compressed CO2 or air 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. Special attention shall be paid to the minimisation of spray drift, and in
particular to the avoidance of drift beyond the boundaries agreed with the owner of the
trial site.
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 field protocol and approval controls.
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12. The personnel applying the substance to the crops shall be able to demonstrate that they
have the qualifications necessary to carry out the trial. One way of demonstrating this
would be the holding of an appropriate Growsafe certification.
13. No produce from within the trial site (including the buffer zone) shall be consumed by
people or animals or offered for sale.
14. Produce from within the trial site (including the buffer zone) shall be disposed of by
ploughing in, by mulching or by burial at an approved landfill (not to be diverted to any
composting operation).
15. 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.
16. The 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.
17. Surplus substance remaining at the end of the trial shall be returned to Syngenta Crop
Protection Limited for secure storage in an exempt laboratory, exported or degraded to a
non-hazardous substance. (Note that once the trials are complete the substance does not
have an approval to be present in New Zealand except in an exempt laboratory).
18. Any accidental spillage of the unmixed substance or spray mix shall be contained,
prevented from entering waterways, and absorbed with an appropriate absorbent material.
This material will be placed in sealed containers and disposed of at an appropriate waste
disposal facility (which may include a landfill), subject to the facility’s waste acceptance
policy.
19. A record shall be kept of all use of the substance. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Class 6, 8 and 9 Controls)
Regulations.
20. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
location, start, and completion of the trials, at least three working days prior to the trials
commencing. The OSH project manager shall be informed at least three working days
prior to application at specific sites. Notification can be by facsimile or e-mail.
21. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s ecotoxic properties, acute toxic properties, irritant properties and
flammability shall accompany the substance at all stages of its lifecycle. Relevant first
aid measures for immediate action pending medical attention shall accompany the
substance at all stages of its lifecycle.
22. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
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23. If for any reason a breach of containment occurs, the Trial Director shall notify OSH 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. 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.
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