ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
19 October 2004
Application Code
HSC04025
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
Dow AgroSciences (NZ) Limited
Waireka Research Station
18 Sutton Road
Omata RD3
Purpose of the Application
New Plymouth
To import or manufacture under containment for field
testing WRS-X-F1, WRS-X-F2 and WRS-X-F3 for the
purpose of control of plant-damaging organisms in
various horticultural crops
Date Application Received
20 September 2004
Consideration Date
19 October 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 WRS-X-F1,
WRS-X-F2 and WRS-X-F3 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:
WRS-X-F1
WRS-X-F2
WRS-X-F3
ERMA New Zealand Decision: Application HSC04025
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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.
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 20 September 2004 and assessed as having
sufficient information on 21 September 2004.
3.2
Project Team:
Beth Dye
Programme Manager, Applications (Hazardous
Substances)
Sue Scobie
Senior Adviser (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, including confidential appendices.
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
ERMA New Zealand Decision: Application HSC04025
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non-confidential information provided from a public health perspective (nonoccupational).’
3.6
The applicant was provided with a copy of the proposed controls for WRS-X-F1, WRSX-F2 and WRS-X-F3 and given the opportunity to comment on them. The applicant
replied that they had no comments to make on the proposed 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 or manufacture WRS-X-F1, WRS-X-F2 and
WRS-X-F3 into containment for field testing for the purpose of control of plantdamaging organisms in various horticultural crops.
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
The applicant has provided the following details of the lifecycle.
4.6
A small volume of WRS-X-F1, WRS-X-F2 or WRS-X-F3 (maximum ten litres of each
formulation) will be imported or produced locally in a laboratory which meets the
requirements of an exempt laboratory under section 33 of the HSNO Act. The
imported substances will be air freighted into Auckland under the management of a
shipping agent, held in a secure facility for customs clearance and then transhipped by
air to New Plymouth Airport. From New Plymouth Airport they are taken immediately
by road to Waireka.
4.7
The substances will be stored in their original labelled containers in a purpose-designed
secure facility until dispensed into the quantities required for a trial (trial samples). The
trial samples will be dispensed into labelled containers just prior to use.
4.8
The trial samples will be diluted and the spray mixture will be applied to the target
crops using a purpose-designed precision sprayer that is capable of applying the spray
mix to the crop so that there is minimal surplus for disposal.
ERMA New Zealand Decision: Application HSC04025
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4.9
At Waireka Research Station (WRS) the used containers that are reusable will be
washed and the washings disposed of in a controlled deactivation system or within the
trial site. Non-reusable containers will be burned in the company-owned high
temperature incinerator. At external sites the sample containers will be rinsed and the
rinsate disposed of within the trial site. The containers will be either returned to WRS
or buried at a licensed landfill.
4.10
Treated produce will be disposed of in an on-site pit from which animals and birds are
excluded, or by burying at a licensed landfill, or by ploughing in or mulching. The site
will be closed off by cultivation of treated annual crops and by disposal of harvested
produce from perennial crops. The same site will not be reused for another application
of the same substance. Any of the substance unused at the end of the project will be
returned to the originating laboratory.
Hazardous Properties
4.11
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.
4.12
The applicant states that for the purposes of this application, hazardous properties have
been determined from the Safety Data Sheets for the substances, and from component
data. The applicant has determined that WRS-X-F1 triggers thresholds for target organ
systemic toxicity, and aquatic ecotoxicity; WRS-X-F2 triggers thresholds for
flammability, skin and eye irritation, target organ systemic toxicity and aquatic
ecotoxicity; WRS-X-F3 triggers thresholds for eye irritation, target organ systemic
toxicity and aquatic ecotoxicity.
4.13
I have reviewed the applicant’s hazard information. This is insufficient to fully
describe the hazards of the substances but provides a workable basis for setting the
containment controls to ensure that any risks can be adequately managed.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.14
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.
4.15
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
4.16
If released into waterways, the substances have the potential to cause adverse effects on
aquatic organisms. If an incident resulting in its spillage near an ignition source occurs,
WRS-X-F2 may cause or accelerate a fire.
ERMA New Zealand Decision: Application HSC04025
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4.17
On the basis of the lifecycle of the substances outlined in paragraphs 4.5 – 4.10,
adverse effects could arise from:
 An accident during storage, use or transportation, resulting in release of the
substance
 Failure to follow correct disposal procedures as outlined in the Management Plan.
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 the environment.
Risks to Human Health and Welfare
4.19
If any of the substances are ingested, if WRS-X-F2 or WRS-X-F3 contacts eyes, or if
WRS-X-F2 contacts skin, there is the potential to cause adverse effects on human
health. If an incident resulting in its spillage near an ignition source occurs, WRS-X-F2
may cause or accelerate a fire.
4.20
On the basis of the lifecycle of the substances outlined in paragraphs 4.5 – 4.10,
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.
4.21
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.
Māori issues and concerns
4.22
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”.
4.23
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
ERMA New Zealand Decision: Application HSC04025
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






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, WRS-X-F1, WRS-X-F2 and WRS-X-F3 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 WRS-X-F1, WRS-X-F2
and WRS-X-F3, 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 WRS-X-F1,
WRS-X-F2 and WRS-X-F3 is thus approved pursuant to section 32 of the Act, with
controls as set out in Appendix 1.
Bas Walker
Date 19 October 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Decision: Application HSC04025
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ERMA New Zealand Approval Code:
WRS-X-F1:
WRS-X-F2:
WRS-X-F3:
HSC000121
HSC000122
HSC000123
ERMA New Zealand Decision: Application HSC04025
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Appendix 1: List of controls that apply to the
hazardous substances WRS-X-F1, WRS-X-F2 and
WRS-X-F3
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 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 substances shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS8409.
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.
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.
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 substances shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 1999.
12. The substances 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 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.
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).
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 Dow
AgroSciences Ltd for secure storage in an exempt laboratory, exported or degraded to
non-hazardous 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 (Class 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
their lifecycle. Personal protective equipment shall be worn when handling the
substances throughout their lifecycle.
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
ERMA New Zealand Decision: Application HSC04025
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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
WRS-X-F1
HSC04025
HSC000121
Beth Dye
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
WRS-X-F2
HSC04025
HSC000122
Beth Dye
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
WRS-X-F3
HSC04025
HSC000123
Beth Dye
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 WRS-X-F1 that shall be imported or manufactured under
this approval is ten litres. The maximum total quantity of WRS-X-F2 that shall be
imported or manufactured under this approval is ten litres. The maximum total quantity
of WRS-X-F3 that shall be imported or manufactured under this approval is ten litres.
ERMA New Zealand Decision: Application HSC04025
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