ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
5 May 2003
Application code
Application type
HSC02010
To manufacture or import a hazardous substance into containment
under Section 31 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Applicant
BOC Gases (NZ) Limited
Purpose
To research and develop a completely automated pesticide
application system for enclosed environments like greenhouses
Date received
20 September 2002
Consideration date
2 May 2003
Considered by
Hazardous Substances Standing Committee of the Authority.
1
Summary of Decision
1.1
The application to manufacture in containment the hazardous substance
ArmourCrop-Insecticide [Methomyl] is approved with controls in accordance with
the relevant provisions of the Hazardous Substances and New Organisms Act 1996
(the HSNO Act), the HSNO Regulations, 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:
ArmourCrop-Insecticide [Methomyl]
1.3
The Committee has adopted the European Union use classification system as the
basis for recording the nature and uses of substances approved. The following use
categories are recorded for these substances:
Main category
Industry category
Function/use category
3
1
38
Non-dispersive use
Agricultural Industry
Pesticides
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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 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 report 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 2002 and stalled on 2
October 2002 for more information. The application was verified on 31 March 2003.
3.2
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 - ACVMG).
 The Department of Conservation.
3.3
The Ministry of Health responded that it had no comments to make relating to this
application.
3.4
The ACVM Group confirmed that the product would require a provisional pesticide
registration, but as at 9 April 2003 had not yet received an application. The ACVM
Group stated that “any issues which may arise under the Acts administered by MAF
and NZFSA would be considered as part of that application (once received).”
3.5
The information available to the Committee comprised:
 The application including as attachments commercially sensitive information
 The ERMA New Zealand Evaluation and Review Report
4
Consideration
Sequence of the Consideration
4.1
In accordance with section 19(2)(b) of the HSNO Act, the Authority appointed Mr.
Tony Haggerty (Chairperson), Dr Max Suckling, and Dr Lin Roberts to consider the
application. The application was considered on 5 May 2003.
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4.2
In accordance with section 32 of the Act, the approach adopted by the Committee
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 applicant states that the purpose of the application is to seek approval to
manufacture the new hazardous substance ArmourCrop-Insecticide [Methomyl] for
trial work. ArmourCrop-Insecticide [Methomyl] is a non-aqueous formulation
containing the active ingredient methomyl in a volatile solvent. The formulation is
pressurised with carbon dioxide, in a gas cylinder, and is spread over the target crops
as a ‘cold fog’. The aim of the trial work is to determine the efficacy of the cold fog
delivery system, and of the substance, in controlling whitefly infestation on tomato,
cucumber, capsicum and eggplant crops grown in greenhouses.
4.4
As the purpose amounts to “research and development on any hazardous substance”,
the Committee considers that the application qualifies for consideration under
section 30(ba).
Hazardous properties of the Substance
4.5
The Committee acknowledges that the physical properties and hazard properties of
the substance have been adequately described by the applicant and assessed by
ERMA New Zealand.
4.6
The Committee notes that a containment application does not require a rigorous
assessment of the hazard classification but only sufficient understanding of the
hazardous properties to ensure that the containment controls are appropriate and
adequate. ERMA New Zealand has assessed the hazardous properties in sufficient
detail and based on verifiable evidence to satisfy the requirements of a containment
application.
4.7
The Committee agrees with ERMA New Zealand that the substance triggers the
following hazard endpoints:
Hazard Effect
Acute toxicity (oral)
Aquatic ecotoxicity
Terrestrial invertebrate ecotoxicity
Terrestrial vertebrate ecotoxicity
Assessment
Triggered
Triggered
Triggered
Triggered
Identification and Evaluation of the Significant Risks of the Substance
4.8
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Committee
considered the potential risks of escape from containment under the headings of
environmental, human health and welfare and Māori issues and concerns.
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4.9
The applicant has identified a number of risks to the environment and to human
health and welfare. The Committee accepts the applicant’s risk assessment and
considers that, taking into account the proposed containment regime and controls in
place under other legislation, there are no significant risks to the environment or to
human health and welfare.
4.10
On the basis of information in the Evaluation and Review report the Committee
considers there are no issues or concerns to Māori.
5
Containment and Controls
5.1
The Committee evaluated the adequacy of the containment arrangements of the
applicant and the proposed controls in the Evaluation and Review Report. The
Committee notes that these cover the following requirements, thereby addressing the
matters set out in Part III of the Third schedule of the Act.
 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 substances.
 To control the effects of any accidental release of the substances.
 Inspection and monitoring requirements.
 Qualifications required of the person responsible for implementing the controls.
5.2
The Committee is satisfied that with adherence to the management plans proposed
by the applicant, and the controls listed in Appendix 1, the substance can be
adequately contained.
6
Decision
6.1
The Committee has considered this application under section 31 to manufacture in
containment hazardous substances, and pursuant to section 32, the Committee is
satisfied that this application is for one of the purposes specified in section 30, being
section 30(ba).
6.2
The Committee is satisfied that given the controls imposed, the substance can be
adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology the Committee records that,
in reaching this conclusion, it has applied the criteria specified in section 32 of the
Act.
6.4
It has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 21 – the decision accords with the requirements of the Act and
regulations;
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

6.5
clause 22 – the evaluation of risks – relevant considerations;
clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
The application to manufacture in containment the hazardous substance
ArmourCrop-Insecticide [Methomyl] is thus approved, with controls, as set out in
Appendix 1.
Mr Tony Haggerty
Date
5 May 2003
Chair, Hazardous Substances Committee
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Appendix 1: Controls
1. TO LIMIT THE LIKELIHOOD OF ESCAPE OF ANY CONTAINED HAZARDOUS
SUBSTANCES OR CONTAMINATION BY HAZARDOUS SUBSTANCES
1.1.
The trials shall be undertaken in accordance with the submitted Project Plan, except
where the following controls direct otherwise. Modifications of the Project Plan may
be approved in writing by ERMA New Zealand providing that they comply with the
following controls.
1.2.
The substance shall be manufactured only within the Crop & Food Research
Envirosol Research Laboratory.
1.3.
The substance shall be applied to the test crops only by means of the automated
delivery system into the designated greenhouses.
1.4.
Treated produce shall be disposed of by a professional waste management company.
1.5.
No treated produce shall be consumed by people or animals or offered for sale.
1.6.
Access to the trial site(s) shall be by permission of the Trial Director. All potential
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.
1.7.
The substance ArmourCrop-Insecticide [Methomyl] shall be securely packed in
cylinders that meet the requirements of the Dangerous Goods (Class 2 - Gases)
Regulations 1980, and which appropriately identify the substance, and provide
warning of the hazard profile of the substance.
1.8.
The substance ArmourCrop-Insecticide [Methomyl] may not be taken outside of the
Crop & Food Research facility, except for authorised disposal.
1.9.
Any portion of the substance surplus to requirements shall be disposed of by the
following method:
 Returned to the Envirosol Research Laboratory for safe storage.
 Released into a scrubber which separates concentrate from the gas, and the
concentrate is collected and disposed of by a professional chemical disposal
company.
2. TO EXCLUDE ORGANISMS OR CONTROL ORGANISMS
2.1.
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 6.6. (See also
Control 1.6).
3. TO EXCLUDE UNAUTHORISED PEOPLE
3.1.
No person shall be permitted to be present in the glasshouses during the period when
the substance is applied to the test crops.
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3.2.
Access to each trial site(s) shall be by permission of the Trial Director or Director of
the research facility. The trial facility or site(s) shall be secured and all potential
access points shall be signed indicating that unauthorised access is not allowed, that
the site is subject to a trial, and that the crops or produce should not be removed or
disturbed.
4. TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCES BY
EXPERIMENTERS WORKING WITH THE SUBSTANCES
4.1.
The amount of the substance prepared for the trial shall be pre-measured so as to be
sufficient for application at the trial.
4.2.
Greenhouse vents shall be closed before and during application of the substance.
4.3.
Spraying will be done in accordance with NZS 8409:1999.
4.4.
The containers and delivery system will be tested prior to use using liquid CO2 to
ensure there are no leaks.
5. TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE
SUBSTANCES
5.1.
To minimise the effects of any accidental release of the substance, an MSDS bearing
appropriate safety precautions and relevant first aid measures for immediate action
pending medical attention shall be made available with each cylinder of substance.
5.2.
Should an accidental release and exposure occur, normal precautions (such as the
careful washing of hands, face, clothing, and equipment) shall be observed.
6. INSPECTION AND MONITORING REQUIREMENTS
6.1.
The Trial Director shall keep track of all use of the substance as per section 5.9.1 of
the Code of Practice for the Management of Agrichemicals NZS8409: 1999.
6.2.
Occupational Safety & Health, Head Office [Attn HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
start and completion of the trials.
6.3.
If a breach of containment occurs, the Trial Director shall notify OSH and ERMA
New Zealand within 24 hours of the breach being detected.
6.4.
The Authority or its authorised agent or properly authorised enforcement officers,
may inspect the facilities and trial sites at any reasonable time in accordance with the
Project Plan.
6.5.
This approval is for 1 year from the date at which BOC Ltd notifies ERMA New
Zealand of the trial’s commencement.
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6.6.
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.
7. QUALIFICATIONS REQUIRED OF THE PERSON RESPONSIBLE FOR
IMPLEMENTING THE CONTROLS
7.1.
The personnel applying the substance to the crops shall be GROWSAFE certified.
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