ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
1 September 2003
Application Code
HSC03004
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 fungicide NZF1 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
24 July 2003
Consideration Date
1 September 2003
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import or manufacture NZF1 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:

NZF1
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.
ERMA New Zealand Decision: Application HSC03004
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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 purpose of the application is to import and to conduct small scale field trials to
evaluate whether the fungicide NZF1 is suitable for use in New Zealand agriculture and
horticulture, and to provide data for a future application for approval for release and
application for registration of a trade name product to the Agricultural Compounds and
Veterinary Medicines (ACVM) Group of the New Zealand Food Safety Authority
(NZFSA).
3.2
The application was formally received on 24 July 2003 and verified as having sufficient
information on 7 August 2003.
3.3
The applicant supplied the following documents that included information identified as
confidential:
 The application;
 Formulation details (confidential appendix);
 Chemical and physical properties of NZF1 and of the active ingredient (confidential
appendix);
 Material Safety Data Sheets for each component (confidential appendix);
 Summary of hazardous properties and threshold data for the active ingredient
(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 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.
3.6
The ERMA New Zealand Senior Advisor (Māori Affairs) was advised of the
application. Her comments form the basis of paragraphs 4.34 and 4.35 of this decision.
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).
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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 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 fungicide NZF1, to conduct small scale
field trials to ascertain its efficacy and residue profile for controlling fungal diseases in
potatoes, tomatoes, onions, grapes, pome fruit, kiwifruit, citrus, cereal crops and
brassica.
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.
International status
4.5
The applicant advises that all non-active ingredients in the formulation are contained in
products that are currently in use in New Zealand. The active ingredient is not currently
contained in any product that is in use in New Zealand.
4.6
NZF1 is still in the experimental stage worldwide and is currently being trialled (with
necessary approvals obtained, where required) in a selection of European, Asian,
African, North American and South American countries.
Hazard Classification
4.7
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.
4.8
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.
4.9
NZF1 consists of an aqueous solution of a fungicide and several excipients.
4.10
The applicant has assessed the hazardous properties for NZF1 and has identified that the
hazard properties of this substance are its toxic (acute toxicity), irritant (dermal and
ocular) and ecotoxic (aquatic and terrestrial vertebrate toxicity) properties.
4.11
Given its stage of development, there are some gaps in the toxicity data for NZF1,
particularly in relation to chronic toxicity studies and information on the decomposition
and movement of the substance in soil.
4.12
I have reviewed the applicant’s hazard information and consider that it sufficiently
describes the known hazards associated with NZF1.
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Life cycle
4.13
Syngenta Crop Protection Limited plans to import up to 50 litres of NZF1 fully
formulated and packaged, into New Zealand. The applicant advises that it will be stored
in suitable facilities maintained by the researchers involved with the trials, in
accordance with the Code of Practice for the Management of Agrichemicals
NZS8409:1999.
4.14
The applicant advises that the substance will be securely packed in containers that will
be identified in accordance with the Hazardous Substances (Identification) Regulations
2001 and a MSDS will accompany each shipment. The label or MSDS will carry
appropriate safety precautions and relevant first aid measures of immediate action
pending medical attention.
4.15
The applicant advises that the substance will be transported to the trial facility, where it
will be dispensed and diluted. The applicant advises that transportation of the substance
will comply with The Land Transport Rule: Dangerous Goods 1999, while the mixing
of the substance will comply with section 5.5 of the Code of Practice for the
Management of Agrichemicals NZS8409: 1999.
4.16
The applicant advises that small scale trials will be undertaken on research facilities and
/or commercial growers’ properties in the following regions: Northland, Auckland,
Waikato, Bay of Plenty, Poverty Bay, Hawkes Bay, Manawatu, Wellington,
Marlborough, Nelson, Canterbury and Southland. The applicant advises that trial sites
will be selected either on the basis that there is a high probability of the target pest
species being present or occurring or that the site will provide other information
necessary for evaluation of the substance.
4.17
The applicant advises that trial sites will be clearly marked as such, with stock proof
fencing at the boundaries of the property. Access to the trial sites will be restricted.
4.18
The applicant advises that appropriate trial sites will be chosen so that the substance will
not enter any surface water or ground water system.
4.19
The applicant advises that trial plots will be of a sufficient size for the evaluation of the
substance and appropriate for the crop type being assessed e.g. up to 3000 m2 for broad
acre crops such as Potatoes, Onions, Brassicas and Cereals and up to 300 trees or vines
for Apples, Citrus, Kiwifruit and Grapes. The number of trials carried out will vary
from year to year and may be up to 20 in total in any one year over the period of
evaluation proposed.
4.20
The applicant advises that the trials will be conducted over the next five years, to ensure
that sufficient disease pressure is found in various locations to give adequate data for
evaluation and for sufficient numbers of trials to be conducted to meet regulatory
requirements.
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4.21
The applicant advises that application to the trial crops will be by hand-held spray boom
application equipment, using hydraulic pressure or compressed carbon dioxide or air.
Spraying will be in accordance with the NZS8409:1999 Code of Practice for the
Management of Agrichemicals.
4.22
The applicant advises that any surplus mixed product will be disposed of at the trial
site(s) by being further diluted and sprayed over a marked and designated non-crop and
non-grazed area at the site, and that the equipment used will be rinsed after use with
fresh water and appropriate cleaning fluid such as detergent or chlorine based
decontaminant, and rinsate similarly disposed of.
4.23
The applicant advises that treated produce will be disposed of by ploughing in,
mulching, or at an appropriate local authority landfill if no approval has been given for
the sale of treated produce.
4.24
The applicant advises that any surplus substance will be disposed of by being returned
to Syngenta for re-use in other trials, by disposal in an appropriate local authority
landfill (pre-treatment at a hazardous waste facility may be required), or by dilution
with water or soil and spread over a designated non-crop, non-grazed waste area at the
trial sites. The applicant also advises that, if registered under the ACVM Act, the
product may be given to a commercial grower to use.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.25
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.
4.26
The applicant addressed the risks within the context of the application.
Risks to the Environment
4.27
I note that some ecotoxicity studies (for example, soil studies) are incomplete.
However, 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.
4.28
Taking into account the lifecycle of the substance outlined in paragraphs 4.13 to 4.24,
exposure 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);
ERMA New Zealand Decision: Application HSC03004
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

4.29
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;
Removal of the product from the trial site by water, air or carried on workers’
clothing.
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 (such as the Land Transport Rule for Dangerous Goods), there are no
significant risks to the environment.
Risks to Human Health and Welfare
4.30
I note that some toxicity studies, especially chronic studies, are incomplete. However,
the applicant has identified that oral, dermal or ocular exposure to NZF1 could result in
adverse effects on human health and welfare, through its acute toxicity and irritating
properties.
4.31
Taking into account the lifecycle of the substance outlined in paragraphs 4.13 to 4.24,
exposure to NZF1 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 by 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.
4.32
Owing to the significant gaps in the toxicological data for NZF1, it is not known what
effects may arise from the consumption of treated produce by animals or people.
4.33
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 (such as the
Land Transport Rule for Dangerous Goods), there are no significant risks to human
health and welfare.
Māori issues and concerns
4.34
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”.
ERMA New Zealand Decision: Application HSC03004
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4.35
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. 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 (such as the Land
Transport Rule for Dangerous Goods).
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
Controls listed in Appendix 1 will minimise exposure to the substance (for example,
through the use of protective clothing by workers, restriction on people accessing the
trial site and the destruction of treated produce), thereby mitigating the likelihood of
adverse effects on the human population that could arise from the substance’s acute
toxicity and its skin and eye irritancy.
5.3
Controls listed in Appendix 1 will minimise the likelihood that the substance will enter
waterways or environments outside the trial sites (for example, by maintaining a
reasonable distance of the trail sites from water sources, and by conducting the trials in
clearly marked trial sites), thereby mitigating the likelihood of adverse effects on
aquatic organisms or terrestrial vertebrates.
5.4
Additional controls are in place to protect the security of the trial facilities and the
integrity of the trial, and to ensure appropriate management of the trial facilities.
5.5
With respect to the applicant’s intention to sell treated produce if ACVM approval has
been given (as described in paragraph 4.23), I advise that produce treated with NZF1 is
not able to be sold but must be disposed of by ploughing in, mulching or by disposal at
an appropriate local authority landfill.
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5.6
With respect to the applicant’s intention to dispose of NZF1 by supplying it to
commercial growers or by use in other trials (as detailed in paragraph 4.24), I advise
that NZF1 is only permitted to be used in trials approved under this approval, to
generate the necessary information for future regulatory approvals in accordance with
the applicant’s stated purpose of this application. Surplus NZF1 may not be used by
non-approved commercial or research facilities or in any manner contrary to this
approval. Surplus NZF1 shall therefore be returned to Syngenta Crop Protection
Limited for secure storage in an exempt laboratory, exported or degraded to a nonhazardous 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.
5.7
Therefore, I am satisfied that with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, NZF1 can be adequately contained.
6
Decision
6.1
I have considered this application under section 31 to import the hazardous substance
NZF1 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 NZF1 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.
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 manufacture into containment the hazardous substance NZF1 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
Decision code
NZF1
HSC000046
ERMA New Zealand Decision: Application HSC03004
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Appendix 1: List of controls that apply to the
hazardous substance NZF1
1. The trials shall be undertaken in accordance with the information contained within the
applicant’s application and with a field protocol (including the identification of the trial
sites) written at the start of each trial season. The field protocol shall be approved by
ERMA New Zealand before the trial commences.
2. Notwithstanding the requirements of control 1 above, the trials shall comply with
controls 3 to 26 below.
3. The maximum quantity of NZF1 that shall be imported is 50 litres.
4. 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;
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. An adequate buffer zone shall be maintained between the trial site and any building
where people live or work.
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. NZF1 shall be imported and stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS8409:1999.
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 transportation of the substance shall comply 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.
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.
ERMA New Zealand Decision: Application HSC03004
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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. Special attention shall be paid to the avoidance of drift beyond the boundary of the trial
sites. Sufficient buffer zones must be maintained to ensure that commercial produce does
not come into contact with the NZF1 spray.
14. No produce from within the trial site (including the buffer zone) shall be consumed by
people or animals or offered for sale.
15. 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).
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. 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.
18. Surplus substance 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).
19. Any accidental spillage of the unmixed substance or spray mix shall be diluted with
water, sand or earth, and then spread over a marked and designated non-crop and nongrazed area within the trial site.
20. 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.
21. 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. The OSH project manager shall be informed
at least three working days prior to application at specific sites.
22. Appropriate safety precautions necessary to provide safeguards against the substance’s
ecotoxic properties, acute toxic properties and skin irritant properties shall accompany the
substance at all stages of its lifecycle.
23. Relevant first aid measures for immediate action pending medical attention shall
accompany the substance at all stages of its lifecycle.
24. 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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25. 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.
26. The trial must be completed within five years of the date of this approval.
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