ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
14 November 2006
Application Code
HSC06022
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (the Act)
Applicant
BOC New Zealand Limited
Private Bag 93 300
Otahuhu
Auckland
Purpose of the Application
ArmourCrop-Insecticide [Methomyl]: to manufacture in
containment this formulation containing methomyl as the active
ingredient based in pressurised liquid carbon dioxide for
automated greenhouse application to control whitefly (field trial).
Date Application Received
29 September 2006
Consideration Date
13 November 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
SUMMARY OF DECISION
1.1
The application to import into containment the hazardous substance, ArmourCropInsecticide [Methomyl], is approved with controls in accordance with the relevant
provisions of the Act and the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substance has been given the following unique identifier for the ERMA New Zealand
Hazardous Substances Register:
ArmourCrop-Insecticide [Methomyl] (HSC06022): HSC000252
2
LEGISLATIVE CRITERIA FOR APPLICATION
2.1
The application was lodged pursuant to section 31 of the Act. The decision was
determined in accordance with section 32, taking into account additional matters to be
considered in that section and matters specified under Part II of the Act and the provisions
of Part III of the Third Schedule of the Act. Unless otherwise stated, references to section
numbers in this decision refer to sections of the Act.
2.2
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.
3
APPLICATION PROCESS
3.1
The application was formally received on 29 September 2006.
3.2
Project Team:
Bella Whittle
Advisor (Hazardous Substances)
Tania van Maanen
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Maori Unit
Report review and sign-out by:
Noel McCardle
Senior Advisor (Hazardous Substances)
3.3
The applicant supplied the following documents:
 the application;
 the decision document of the previous approval to manufacture or import into
containment AromourCrop-Insecticide [Methomyl] (HSC02010). This approval was
issued on 5 May 2003 and expired on 5 May 2004;
 a confidential appendix containing details of the composition of the formulation and a
diagram of the layout of the containment facility.
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 (Workplace Group);
 the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for ArmourCropInsecticide [Methomyl] and given the opportunity to comment on them. The comments
provided were taken into account 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 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.
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Purpose of the application
4.3
The purpose of the application is to conduct further contained field trials on ArmourCropInsecticide [Methomyl]. A previous containment approval (HSC02010) was granted for
initial work to research and develop an automated application system using this substance.
ArmourCrop-Insecticide [Methomyl] is a non-aqueous formulation containing the active
ingredient methomyl in carbon dioxide (CO2) gas. The formulation is pressurised with
CO2 in a gas cylinder, and is spread over the target crops as a ‘cold fog’. The product is
intended greenhouse application to control whitefly. The aim of this trial is to assess the
scale up effects of efficacy, produce tolerance and environmental monitoring of this
technology.
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 technical grade active ingredient, methomyl, will be supplied to Nufarm NZ Ltd by
DuPont NZ Ltd. A 10% concentrate will be formulated by Nufarm NZ, Auckland and
supplied to BOC NZ Ltd.
4.6
ArmourCrop-Insecticide [Methomyl] will be manufactured at BOC’s Envirosol Product
Filling Plant located in Penrose, Auckland. The substance will be filled in stainless steel
cylinders with liquid carbon dioxide. Fifteen Type G cylinders, each containing 31 kg of
product containing 1% methomyl will be manufactured under this approval. This quantity
of product will allow for about 9 spray applications to be carried out. The applicant
advises that this equates to 50 kg or product per application for a greenhouse size
estimated at about 50 000m3.
4.7
Full cylinders will be labelled indicating that they are for experiment only and stored
securely outside the filling site in an open and ventilated space.
4.8
Transportation of cylinders to the trial site will be coordinated by BOC’s cylinder
distribution trucks. This will comply with the Land Transport Rule: Dangerous Goods
2005.
4.9
In order to prevent contamination, before dispensing the dose into the greenhouse, the
delivery system will be pressure tested using liquid CO2 to minimise accidental release.
4.10
The experimental cylinder will be connected to an automated dispensing system. The dose
will be applied remotely (based on weight) into one commercial greenhouse in the evening
after workers have left. Application will be conducted in accordance to standard fogging
procedures detailed in Section 5 of the Code of Practice, NZS 8409:2004 Management of
Agrichemicals. All vents will be closed to ensure minimal external air exposure. All vents
will remain closed during the duration of the treatment and for a further 8 hours after
treatment.
4.11
The greenhouse will be fully vented for 2 hours before the re-entry of workers. Contact
entry will be allowed at 24 hours, and non-contact entry may occur at 12 hours. The
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applicant advises this is similar to the re-entry periods for water-based formulations
containing the active ingredient methomyl.
4.12
The applicant intends any surplus substance to be disposed of by either returning to
BOC’s Penrose facility; or released into a scrubber which separates concentrate from
gaseous CO2 and the concentrate collected and disposed of by a professional disposal
company.
4.13
The applicant intends that the treated produce will be offered for sale. The Agency notes
that any treated produce intended for human or animal consumption, or offered for sale
shall need to comply with New Zealand Food Safety Authority (NZFSA) requirements
with respect to application rate, withholding period and maximum residue levels. Produce
not covered under a NZFSA approval is not to be used for consumption, nor offered for
sale.
Hazardous properties
4.14
The Agency notes that a containment application only requires sufficient understanding of
the hazardous properties to ensure that any risks can be managed by the containment
controls.
4.15
The Agency also notes that the scope of the hazard information will often be limited for
containment applications, as the substance will be experimental and may not be
commercialised. However, in this case, the Agency notes that sufficient information is
available on this substance to assign a hazard classification of 6.1D, 6.4A, 6.8B, 6.9A, 9.1B,
9.2C, 9.3C, and 9.4B.
4.16
I have taken this into account in my review of the substances’ likely hazardous properties,
and consider that the information is sufficient for me to determine that any risks can be
managed by the containment controls.
Identification and evaluation of the significant risks of the substance
in containment
4.17
The applicant has identified and assessed potential risks and detailed proposals for, and
impacts of, risk management. The Agency has reviewed the applicant’s assessment of the
risks to the environment, human health and welfare and Maori issues and concerns as set
out below:
Risks to the environment
4.18
If released off target, the substance has the potential to result in adverse effects on the
environment. The substance is considered by the Agency to be ecotoxic in the aquatic
envrionment (9.1B), harmful in the soil environment (9.2C), harmful to terrestrial
vertebrates (9.3C) and ecotoxic to terrestrial invertebrates (9.4B).
4.19
On the basis of the lifecycle of the substance outlined in paragraphs 4.5-4.13, adverse
effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substance;
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

failure to follow the correct operational procedures as set out in the controls and
containment system as described in the application, resulting in release of the
substance; or
failure to follow correct disposal procedures.
4.20
I note that limited quantities of the substance will be manufactured and released into
containment, and that the vents of the greenhouse facility will be closed during treatment
and for a further 8 hours to minimise external exposure. I also note that the substance will
be packaged securely in accordance with the relevant UN packing group and that the
intention of the applicant that use, transport and storage will be compliant with relevant
standards and regulations as noted in the lifecycle discussion above.
4.21
I consider that, taking into account the hazardous properties of the substance, the
quantities involved, the containment controls in Appendix 1 and controls in place under
other legislation, there are no significant risks to the environment from this trial.
Risks to human health and welfare
4.22
The Agency considers that ArmourCrop-Insecticide [Methomyl] is acutely toxic (6.1D), an
eye irritant (6.4A), a reproductive and developmental toxicant (6.8B), and a target organ
systemic toxicant (6.9A). The Agency considers that, if the substance is ingested or
inhaled, or comes in contact with skin or eyes it may have the potential to cause adverse
effects on human health.
4.23
On the basis of the lifecycle of the substances outlined in paragraph 4.5-4.13, adverse
effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substance;
 failure to follow the correct operational procedures as set out in the controls and the
containment system, resulting in personnel exposure while contained, or bystander
exposure if released; or
 failure to follow correct disposal procedures.
4.24
I consider that, taking into account the properties of the substance, 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
4.25
ERMA New Zealand has considered this application in accordance with the Methodology
Order 1998 clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the Act. In addition, the
Project Team used the framework contained in the ERMA New Zealand user guide
“Working with Māori under the HSNO Act 1996” to assess this application.
4.26
The applicant and the project team noted that the ArmourCrop-Insecticide [Methomyl]
has hazardous properties that trigger HSNO toxicity and ecotoxicity thresholds. Therefore,
there is the potential that this substance could negatively impact Māori and, or, the mauri
of iwi, cultural tāonga and the environment.
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4.27
The project team has completed its assessment of the application, and has identified the
risks and the appropriate controls necessary to mitigate the substance’s toxic and eco-toxic
properties based on the assessed hazard classifications and after careful consideration of
the following:



storage of ArmourCrop-Insecticide [Methomyl];
packaging, product labelling, handling and transportation procedures; and
appropriately supervised containment-trial use
4.28
Based on this assessment, the Agency is unaware of any impacts that the ArmourCropInsecticide [Methomyl] could have on Māori culture, or, on our traditional relationships
with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. the
Agency has no evidence to suggest that the controlled containment-trial use of the
ArmourCrop-Insecticide [Methomyl] will breach the principles of the Treaty of Waitangi
and see no requirement for the applicant to consult with Māori regarding this application.
4.29
This assessment is made on the condition that the substance is handled, blended, stored,
transported, used and disposed of, in accordance with the explicitly stated HSNO 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 applicant notify the appropriate authorities 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
CONTAINMENT AND CONTROLS
5.1
The Agency has evaluated the adequacy of the containment arrangements proposed by the
applicant and the controls listed in Appendix 1, and notes 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 14);
 to exclude organisms from a facility (for example, control 13);
 to exclude unauthorized people from the facility (for example, control 12);
 to prevent unintended release of the substances by experimenters working with the
substance (for example, control 16);
 to control the effects of any accidental release of the substance (for example, control
25);
 inspection and monitoring requirements (for example, control 28); and
 qualifications required of the person responsible for implementing the controls (for
example, control 18).
5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those controls
in place under other legislation, ArmourCrop-Insecticide [Methomyl] can be adequately
contained.
6
DECISION
6.1
I have considered this application made under section 31 and, pursuant to section 32, I am
satisfied that this application is for the purpose specified in section 30(ba).
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6.2
Having considered the risks associated with the lifecycle of ArmourCrop-Insecticide
[Methomyl], 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 ArmourCropInsecticide [Methomyl] is thus approved pursuant to section 32 of the Act, with controls as
set out in Appendix 1.
Rob Forlong
13 November 2006
Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ArmourCrop-Insecticide [Methomyl] (HSC06022):
ERMA New Zealand Decision: Application HSC06022
HSC000252
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCE, ARMOURCROPINSECTICIDE [METHOMYL]
General
1. The trials shall be undertaken in accordance with the information on the proposed
containment system provided under section four of the application, addressing matters to be
considered under Part III of Schedule 3 of the Act. Modifications of these specifications
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:
Manufacture
3. Manufacture of ArmourCrop-Insecticide [Methomyl] shall take place at the BOC filling site
in Penrose, Auckland, with concentrated Methomyl acquired from Nufarm NZ.
4. A maximum of 15 type G cylinders of ArmourCrop-Insecticide [Methomyl] (each containing
31 kg of the substance) shall be manufactured under this approval.
Packaging and information
5. The substance shall be filled in cylinders that comply with the Hazardous Substances
(Compressed Gasses) Regulations 2001.
6. Each cylinder shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001.
7. A Safety Data Sheet, compliant with the Hazardous Substance (Identification) Regulations
2001, shall accompany each the first delivery of the substance and be held at each trial site
for the duration of the trial.
Storage and transport
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 NZS 8409:2004.
9. The substance shall be transported in accordance with good practice. This would generally
be achieved through compliance with the Land Transport Rule: Dangerous Goods 2005.
Trial conditions
10. The trial sites shall be chosen so as to prevent the substance entering any surface water or
groundwater system.
11. The trial sites shall be located to prevent any building where people live or work being
exposed to the substance.
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12. 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.
13. Access of non-target animals to all trial sites will be controlled for the duration of the trial
period. The trial period means the period of the date of initial application of the substance
to the date of site close off in accordance with control 23.
14. The trial equipment shall be pressure tested with liquid CO2 before any treatment
commences in order to minimise accidental release of the substance from the facility.
15. The substance shall be prepared prior to application in accordance with good practice. This
would generally be achieved through compliance with the Code of Practice for the
Management of Agrichemicals NZS 8409:2004.
16. The substance shall be applied to the test crops only by means of the remote automated
delivery system proposed by BOC New Zealand Ltd, in accordance with good practice. This
would generally be achieved through compliance with the Code of Practice for the
Management of Agrichemicals NZS 8409:2004.
17. All vents to the trial site shall remain closed throughout the duration of, and for a further 8
hours following treatment. No person shall be permitted to be present in the glasshouse
during treatment. The facility shall be fully vented for at least 2 hours before re-entry of any
person.
18. During use, the substance shall be under the control of experimental staff, who are trained
and experienced in the handling and applying the substance under test conditions using the
specified equipment. Personnel applying the substance should be Growsafe certified or hold
an Approved Handlers Certificate. Experimental staff should also be aware of the trial
conditions and the controls in place in order to adequately manage the substance.
19. 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. The substance shall be applied remotely; however, protective clothing, including
safety glasses, gloves shall be kept handy in case of an emergency.
20. Any treated produce intended for human or animal consumption, or offered for sale shall
comply with the requirements of the New Zealand Food Safety Authority (NZFSA) with
respect to application rate, withholding period and maximum residue levels. Produce not
meeting the NZFSA requirements is not to be used for consumption, or offered for sale.
21. After application, any equipment used in the trial shall be cleaned or treated in a manner so
that it no longer contains any hazardous substance.
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with the trial conditions and approval controls.
1
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22. 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 2001.
23. Upon site close off, the Trial Director shall ensure that at the trial site, residue levels for
methomyl shall be below cut-off levels for toxicological or ecotoxicological concern, or
show that the environmental fate of this component is such that it is not readily available and
will not move off the site. This includes any areas used for the preparation or disposal of the
spray mix.
Emergency management
24. Any spillage of the concentrated active ingredient (before filling in cylinders), shall be
contained, prevented from entering waterways, and absorbed into an appropriate absorbent
material. This material shall be placed into sealed containers and disposed of at an
appropriate waste disposal facility, subject to the facility’s waste acceptance policy.
25. Any accidental release of ArmourCrop-Insecticide [Methomyl] cannot be recovered due to
the gaseous nature of the substance. However, pressure testing the delivery system will be
performed to identify any leaks in order to minimise the potential for this to occur.
Disposal
26. Surplus substance remaining at the end of the trials shall be disposed of by one of the
following methods, in a manner compliant with the Hazardous Substances (Disposal)
Regulations 2001:
 returned to BOC New Zealand Ltd in original containers for appropriate treatment and
disposal;
 stored securely in an exempt laboratory under the Hazardous Substances (Exempt
Laboratories) Regulations 2001 (note that once the trials are complete the substance does
not have approval to be present in New Zealand except in an exempt laboratory), or
 released into a scrubber which separates concentrate from the gas, and the concentrate is
then collected and disposed of by a professional chemical disposal company.
27. Cylinders no longer used to contain ArmourCrop-Insecticide [Methomyl], or equipment
used to handle the substance shall be returned to BOC New Zealand Limited, where it will
be appropriately cleaned or treated so that it is no longer hazardous.
Notification and inspection
28. The Department of Labour [Attn. HSNO Project Manager (Workplace Group) P O Box
3705, Wellington] 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
ArmourCrop-Insecticide [Methomyl]
HSC06022
HSC000252
Bella Whittle
29. 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
ERMA New Zealand Decision: Application HSC06022
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detected. It is suggested that if a breach in containment results in contamination of a
waterway, the relevant iwi authorities be advised.
30. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time. Trial documentation,
notwithstanding its confidential nature, shall be available for inspection by any enforcement
officer, upon request.
31. 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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