ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
6 December 2006
Application Code
HSC06024
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
Key Industries Limited
P O Box 65070
Mairangi Bay
North Shore 0754
Auckland
Purpose of the Application
Timorex: To import into containment this fungicide to evaluate
the efficacy, crop safety and residue profile under NZ cropping
conditions (field trial).
Date Application Received
24 October 2006
Consideration Date
5 December 2006
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,
Timorex, 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:
Timorex
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:
David Hodge
Advisor (Hazardous Substances)
Nicola Reeves
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;
 a confidential appendix containing a Safety Data Sheet and formulation composition.
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 Timorex 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 conduct further contained field trials on Timorex to
evaluate the efficacy, crop safety and residue profile under New Zealand cropping
conditions.
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
A maximum of 150 litres (<70 % ai), or equivalent, of Timorex will be imported by
airfreight over a period of three years. The substance will be packed .in either 250ml or 1
litre containers constructed of HDPE. The unopened substance and its packaging will be
transported by road to the premises of the single specific designated field research facility.
It will be kept in a secure locked storage facility that is designated for the storage of
hazardous chemicals at the Field Research facility. The Storage of Timorex will be under
the control and responsibility of the Field Researcher/Study Director.
4.6
Timorex will be used in field trials to evaluate the efficacy of the substance against problem
diseases in New Zealand horticulture. Information on crop safety and the residue profile
will be generated during the course of the trial work. The applicant has formally engaged
Geelen Research to conduct the research and no other parties will be permitted to use the
product without the approval and supervision of the Study Director. The technical
research provider will administer amounts of each product (diluted with water) to treat the
designated treatment areas and individual trees. The only people permitted to use these
materials will be authorised, competent and experienced field researchers of the contracted
research provider who have previous experience in handling research or development
compounds.
4.7
The small area of crop or trees to be treated by hand operated equipment would mitigate
against significant waste. Only sufficient amount of the test material will be prepared in a
water solution for application to the host target at the trial site. This will avoid having
significant remaining spray mixtures requiring disposal. Any excess spray mixtures of the
substance diluted with water will be disposed of at the research facility in an appropriate
manner typical and appropriate for such sites. This includes disposal onto non-crop waste
headland areas. Any empty container will be triple-rinsed with water and crushed and
buried in an appropriate landfill. The rinsate will be disposed of in a similar method to any
excess spray mixture. Empty containers will be disposed of according to the local bylaws
by crushing and burying in an appropriate landfill as per the requirements of the
Hazardous Substance (Disposal) Regulations 2001.
Hazardous properties
4.8
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.
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4.9
The applicant has examined the hazardous nature of Timorex and considers it to be
flammable 3.1C, acutely toxic 6.1E, irritating to the skin 6.3B and ecotoxic in the aquatic
environment 9.1C.
4.10
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 lifecycle of the substance in New Zealand can be managed through the
application of controls as defined in Appendix 1.
4.11
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
4.12
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 Maori issues and concerns
as set out below:
Risks to the environment
4.13
If released into the environment the substance has the potential to result in adverse effects
within the environment.
4.14
On the basis of the lifecycle 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.
4.15
The Project Team considers that the contained import and trialling of Timorex will not
pose any significant risks to the environment. In its consideration, the Project Team took
several factors into account, including the containment regime proposed by the applicant,
the overall quantity of the substance involved, the controls set out in Appendix 1 and the
requirements of other legislation.
4.16
I note that limited quantities of the substance will be manufactured and released into
containment for field trails (i.e. a maximum of 150 litres over 3 years.
4.17
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
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4.18
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 Timorex.
4.19
On the basis of the lifecycle of the substances outlined in paragraph 4.5-4.7, 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.
4.20
I consider 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
4.21
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.
4.22
The applicant and the Project Team have classified Timorex to be flammable 3.1C, acutely
toxic 6.1E, irritating to the skin 6.3B and ecotoxic in the aquatic environment 9.1C. Thus,
there is the potential that this substance could negatively impact Māori and, or, the mauri
of iwi, cultural tāonga and the environment.
4.23
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 physical, toxic and
eco-toxic properties based on the assessed hazard classifications and after careful
consideration of the following:



storage of Timorex;
packaging, product labelling, handling and transportation procedures; and
appropriately supervised containment-trial use
4.24
Based on this assessment, the Project Team is unaware of any impacts that the Timorex
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 Timorex will breach
the principles of the Treaty of Waitangi and see no requirement for the applicant to
consult with Māori regarding this application.
4.25
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
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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, Timorex 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 Timorex, 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), 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
Timorex is thus approved pursuant to section 32, with controls as set out in Appendix 1.
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Rob Forlong
Date: 6 December 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code: HSC000254
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCE, TIMOREX
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. 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 the substances to agricultural
and horticultural crops, forestry, pasture, and seeds.
4. This approval excludes application of substances directly into or onto water.
5. This approval excludes the aerial application of the substance
6. Notwithstanding the requirements of control 1 above, the importation and trials shall also
comply with the following controls:
Import
7. Key Industries may import A maximum of 150 litres (<70 % a.i.), or equivalent, of Timorex
over a period of three years.
Packaging and Information
8. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
9. Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001.
10. The label must also set out instructions that any of the substance remaining after each trial
must be returned in its original container to Key Industries.
11. 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 trial.
Storage
12. The substance shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004.
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Transport
13. 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.
General handling of the substance
14. Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substances, for example during handling,
application and disposal.
Trial Sites
15. 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 34.
16. The trial sites shall be chosen so as to prevent the substance entering any surface water or
groundwater system.
17. 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 substances.
18. 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.
19. 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 and any stock withholding periods set by the
ACVM Group of the New Zealand Food Safety Authority.
Trial Conditions
20. During use the substance shall be under the control of experimental staff, who are trained
and experienced in the handling and administration of fungicides 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.
21. 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.
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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22. 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.
23. The substances 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 18.
24. The trials shall be conducted and managed so as to prevent vertebrates and non- target
invertebrates from coming into contact with the substance throughout the trials.
25. 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.
26. 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 (Class 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.
27. 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.
28. Upon site close off, the Trial Director shall ensure that at the trial site, residue levels for
timorex 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
29. 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
30. Any surplus substance remaining at the ‘end of the trials’ shall be returned to Key industries
where it will 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. ‘End of trials’ is defined as the end of the trial
programme as defined in the project plan for each substance. (Note that once the trials are
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completed the substance will not have approval to be present in New Zealand except within
an exempt laboratory).
31. 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.
32. Containers no longer used to contain the substance and residue or rinsate from equipment
used to handle the substances shall be disposed of in a manner compliant with the
Hazardous Substances (Disposal) Regulations 2001.
33. 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.
Notification and Inspection
34. 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
Timorex
HSC06024
HSC000254
David Hodge
35. 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.
36. 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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