ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
10 May 2007
Application Code
HSC07009
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)
Nufarm New Zealand
Applicant
Purpose of the Application
Matric: to import into containment an insecticide for
research and development (field trials).
Date Application Received
28 March 2007
Consideration Date
10 May 2007
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of Decision
1.1
The application to import into, or manufacture in, containment the hazardous
substance, Matric, 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:
Matric
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 31. 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.
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3 Application process
3.1
The application was formally received on 28 March 2007.
3.2
Project Team:
David Hodge
Advisor (Hazardous Substances)
Chris Geering
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit
Report review and sign-out by:
Noel McCardle
Senior Advisor (Hazardous Substances).
3.3
The applicant supplied the following documents:
 the application; and
 confidential appendixes including formulation data and a 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 (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 Matric 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)).
4.2
In accordance with section 32, 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 import into containment Matric to conduct field
trials to evaluate whether the substance is suitable for use as an insecticide in the New
Zealand horticultural industry and to provide data for a future application for approval
for release.
4.4
As the purpose amounts to “research and development on any hazardous substance”,
the Project Team considers that the application qualifies for consideration under
section 30(ba).
Life-cycle
4.5
Matric will be imported into New Zealand. The substance will be dispensed into trial
quantities as required. The trial sample will then be mixed with water to provide the
spray mixture. The spray mixture will then be applied as detailed in the Project and
Trial Management Plans.
Hazardous properties
4.6
The Project Team 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. The scope of the hazard information will often be limited
for containment applications, as the substance will be experimental and may not be
commercialised.
4.7
The applicant has examined the hazardous nature of Matric and considers it to be
ecotoxic in the aquatic environment (9.1D). It is noted that the applicant had no
information to determine whether the substance is a carcinogen, reproductive or
developmental toxicant or target organ toxicant.
4.8
The Project Team has reviewed the summary data and other information supplied by
the applicant and considers that the information is sufficient to determine that any
risks posed within the defined life-cycle of the substance in New Zealand can be
managed through the application of controls.
Identification and evaluation of the significant risks of the substance in
containment
4.9
The applicant has identified and assessed potential risks and detailed proposals for, and
impacts of, risk management. The Project Team has reviewed the applicant’s
assessment of the risks to the environment, human health and welfare and Māori
issues and concerns as set out below:
Risks to the environment
4.10
If released into the environment, the substance has the potential to result in adverse
effects within the environment.
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4.11
On the basis of the life-cycle of the substance, adverse environmental 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
containment system as described in the application, resulting in release of the
substance; or
 failure to follow correct disposal procedures.
4.12
The Project Team notes that limited quantities of the substance will be manufactured
and released into containment for field trials (i.e. up to 10 L).
4.13
The Project Team considers 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
4.14
The Project Team considers that adverse effects to human health and welfare may
result from exposure(s) to the substance, given the level of detail and related
uncertainty involved in studies conducted for experimental substances such as Matric.
4.15
On the basis of the life-cycle of the substance outlined in paragraph 4.5, 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.
4.16
The Project Team considers that there are no significant risks to human health and
welfare, given 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.
Māori issues and concerns
4.17
The Project Team has considered this application in accordance with clauses 9(b)(i)
and 9(c)(iv) and sections 6(d) and 8. 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.
4.18
The applicant has classified Matric to be ecotoxic in the aquatic environment 9.1D.
Thus, 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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4.19
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 potential
physical, toxic and ecotoxic properties after careful consideration of the following:
 storage of Matric;
 packaging, product labelling, handling and transportation procedures; and
 appropriately supervised containment-trial use.
4.20
Based on this assessment, the Project Team is unaware of any impacts that the Matric
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 Project Team has
no evidence to suggest that the controlled containment-trial use of the Matric will
breach the principles of the Treaty of Waitangi and see no requirement for the
applicant to consult with Māori regarding this application.
4.21
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 Project Team 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;
 to exclude organisms from a facility;
 to exclude unauthorized people from the facility;
 to prevent unintended release of the substances by experimenters working with the
substance;
 to control the effects of any accidental release of the substance;
 inspection and monitoring requirements; and
 qualifications required of the person responsible for implementing the controls.
5.2
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, Matric 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).
6.2
Having considered the risks associated with the lifecycle of Matric, I am satisfied that
the controls imposed, including those in place under other legislation, will result in the
substance being adequately contained.
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6.3
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have
applied the criteria specified in section 32.
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, or manufacture in, containment the hazardous
substance Matric is thus approved pursuant to section 32, with controls as set out in
Appendix 1.
Rob Forlong
Date: 10 May 2007
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
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HSC000275
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Appendix 1: list of controls that apply to Matric
General
1. The trials shall be undertaken in accordance with the Trial Management Plan, Project Plan
and 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. 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.
3. This approval applies only to the ground-based application of Matric. It excludes the aerial
application of the substance.
4. This approval excludes application of the substance directly into or onto water.
5. Notwithstanding the requirements of control 1 above, the importation and trials shall also
comply with the following controls:
Import
6. Nufarm New Zealand may import a maximum of 15 litres of Matric under this approval.
Packaging and Information
7. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
8. Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001.
9. The label must also set out instructions that any of the substance remaining after the trial
must be returned in its original container to Nufarm New Zealand.
10. A Safety Data Sheet, compliant with the Hazardous Substance (Identification) Regulations
2001, shall accompany each shipment of the substance and be held at each trial site for the
duration of the application of the substance.
Storage
11. The substance shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004.
Transport
12. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 or the Maritime
Transport Act 1994.
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General Handling of the Substance
13. Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substance, for example during handling,
application and disposal.
Trial Sites
14. 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:

has written permission from the owner of the land to carry out the trial; and

notifies ERMA New Zealand in writing of the location in accordance with
Control 33.
15. The trial sites shall be chosen so as to prevent the substance entering any surface water or
groundwater system.
16. The trial sites shall be located to prevent any residential building or workplace which is not
related to the research from being exposed to the substance.
17. Access to the trial sites shall be by permission of the Trial Director1, nominated researcher 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 permitted, that the site is
subject to a trial, and that the trial crops should not be removed.
18. Trial sites that are at risk of entry by grazing animals shall be secured by stock proof fencing
to exclude animals for the duration of the trial. Stock proof fencing is not required if a stock
withholding period set by the ACVM Group of the New Zealand Food Safety Authority has
elapsed.
Trial Conditions
19. During use the substance shall be under the control of experimental staff who are trained
and experienced in the handling and administration of insecticides under test conditions
using the specified equipment. Experimental staff should also be aware of the study
protocol and the controls in place in order to adequately manage the substance.
20. The substance shall be mixed, diluted, prepared or otherwise handled in accordance with the
relevant sections of the Code of Practice for the Management of Agrichemicals NZS 8409:
2004.
21. The amount of spray prepared shall be the minimum necessary for the trial, but if there is
any surplus spray mix it shall be disposed of within the trial site by spraying over a marked
and designated non-crop and non-grazed area at the site, or alternatively within the trial plot.
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 Management and Project Plan and approval controls.
1
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22. The substance shall be applied using equipment calibrated to apply accurate doses to the
nominated trial plots in accordance with good practice. This would generally be achieved
through compliance with the Code of Practice for the Management of Agrichemicals
NZS8409:2004 or a Standard Operating Procedure retained as part of the applicant’s trial
records. 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 or occupier of the trial site
and delineated in accordance with Control 17.
23. No sprayed produce shall be consumed by people or (so far as is reasonably practicable)
animals or be sold, offered for sale, given away, bartered or otherwise distributed unless the
ACVM Group has approved this process as part of a provisional registration or research
permit.
24. A record shall be kept of all use of the substance. This record shall cover all matters referred
to in Regulation 6(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations
2001 and must be kept for not less than 3 years after the date on which the substance that
the record relates to is applied or discharged.
25. Any equipment used during application shall be triple rinsed after use with water and if
required with an appropriate detergent or decontaminant, and the rinsate disposed of within
the trial site by being sprayed over a marked and designated non-crop and non-grazed area at
the site, or alternatively within the trial plot.
Emergency Management
26. Any spillage of the substance (diluted or not) shall be contained, prevented from entering
water bodies, and be absorbed with an appropriate absorbent material. The absorbent
material shall be collected and placed in sealed containers for disposal at an appropriate
waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance
policy.
Disposal
27. Any surplus substance remaining at the end of the trials shall be returned to Nufarm New
Zealand where it shall be securely stored in a laboratory complying with the requirements set
out in the Hazardous Substances (Exempt Laboratories) Regulations 2001 for the purpose of
further analysis or until disposed of.
28. Any surplus substance shall ultimately be treated in a manner to render the substance, as a
whole, non-hazardous or be exported from New Zealand. Disposal shall be carried out in a
manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
29. Containers no longer used to contain the substance and residue or rinsate from equipment
used to handle the substance shall be disposed of in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001.
30. Sprayed produce that may be at risk of being removed from the trial after its completion
shall be disposed of by ploughing in, by mulching, by burial on the trial site or by deposition
at an approved landfill. The Trial Director shall decide the method of disposal after assessing
the relevant risks. Sprayed plant matter shall not be added into any composting operation.
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Notification and Inspection
31. The Department of Labour [Attn. HSNO Project Manager (Workplace Group) 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
Matric
HSC07009
David Hodge
32. 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
detected. It is suggested that if a breach in containment results in contamination of a
waterway, the relevant iwi authorities be advised.
33. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time. Trial documentation, as described
in Control 1, notwithstanding its confidential nature, shall be available for inspection by any
enforcement officer, upon request.
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