ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
29 November 2004
Application Code
HSC04030
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
Tower 2, Level 7
110 Symonds Street
Purpose of the Application
Auckland
To import into containment the substances NZH5 and
NZH5A to conduct field trials to provide information for
the development of the selected compounds
Date Application Received
7 October 2004
Consideration Date
19 November 2004
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substances NZH5 and
NZH5A 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 substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
NZH5
NZH5A
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
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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 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 7 October 2004 and assessed as having
sufficient information on 11 October 2004.
3.2
Project Team:
Amanda McKenzie
Applications Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Robinson
Manager, Māori Unit
Report review and sign-out by:
Dr Graeme Dick
Programme Manager (Hazardous Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices, containing compositional information, a Safety Data Sheet,
information on the hazardous properties and intended uses, and the proposed
containment system (Management Plan).
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
 The Department of Labour (Occupational Safety and Health)
 The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
Responses were received from
 The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group) stating that; ‘as this application will be considered under the
ACVM Act, any issues which may arise under the Acts administered by
MAF/NZFSA will be considered as part of that application.’
 The Ministry of Health stating; ‘with appropriate 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 (nonoccupational) given that the substance is intended for experimental purposes only.’
3.6
The applicant was provided with a copy of the proposed controls for NZH5 and
NZH5A and given the opportunity to comment on them. The applicant replied that the
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proposed controls were acceptable, however asked that control 15 relating to the
disposal of sprayed produce, be altered to include the desiccation of the crop by
herbicide application. This comment has been considered in the setting of controls.
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 was for 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 NZH5 and NZH5A into containment to
conduct field trials to evaluate whether the substances are suitable for use in New
Zealand agriculture and horticulture, and to provide data for future applications to
ERMA New Zealand and the ACVM Group.
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 20 litres of NZH5 and 5 kilograms
of NZH5A over a period of five years. I note that the formulation of NZH5 covers a
number of variation, differing in excipients. The substances 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 mixture will be prepared and applied.
Disposal procedures for surplus sample, spray mixture 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 searched for information relevant to the substances but has been
unable to identify the hazardous properties of NZH5 and NZH5A. I note that available
information indicates that NZH5 and NZH5A are likely to trigger the thresholds for eye
corrosiveness, aquatic ecotoxicity and soil ecotoxicity.
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4.8
I have reviewed the applicant’s hazard information and additional information available
and note that there are some gaps in the knowledge of hazardous properties. I have
taken this into account and conclude that any risks of the substances can be managed by
the containment controls.
Identification and Evaluation of the Significant Risks of the Substance 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.
Risks to the Environment
4.11
If released into the environment or waterways, the substances have the potential to
cause adverse effects to aquatic organisms and soil dwelling organisms.
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.
4.13
I consider that, taking into account the likely properties of the substances, the quantity
of the substances 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.
Risks to Human Health and Welfare
4.14
If the substances comes in contact with the eyes, there is the 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.
4.16
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.
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Māori issues and concerns
4.17
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”.
4.18
On the basis of the information provided by the ERMA New Zealand Manager (Māori),
I consider that the substances are 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
substances are 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 (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
substance (for example, control 9)
 To control the effects of any accidental release of the substance (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, NZH5 and NZH5A can be adequately
contained.
6
Decision
6.1
I have considered this application under section 31 to import into containment
hazardous substances, 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 NZH5 and NZH5A, I am
satisfied that the controls imposed, including those in place under other legislation, will
result in the substances being adequately contained.
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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 NZH5 and
NZH5A is thus approved pursuant to section 32 of the Act, with controls as set out in
Appendix 1.
Bas Walker
Date 29 November 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
NZH5: HSC000135
NZH5A: HSC000136
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Appendix 1: List of controls that apply to the
hazardous substance NZH5 and NZH5A
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 substance 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 substance.
6. 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 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 substance shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS8409.
9. The substance 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.
10. The substance 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.
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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11. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 1999.
12. 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 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 boundaries agreed with the owner
of the trial site.
13. The personnel applying the substance 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.
14. No sprayed produce shall be consumed by people or animals or offered for sale.
15. Sprayed produce shall be disposed of by application of herbicide, 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. 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 substance 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 a nonhazardous substance (note that once the trials are complete the substance does not have
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 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 substance. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Class 6, 8 and 9 Controls)
Regulations.
21. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s toxic and ecotoxic properties shall accompany the substance at all stages of
its lifecycle. Personal protective equipment shall be worn when handling the substance
throughout the lifecycle.
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22. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] 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
NZH5
HSC04030
HSC000135, HSC000136
Amanda McKenzie
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. 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 the substances that shall be imported under this approval
is 20 litres of NZH5 and 5 kilograms of NZH5A.
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