ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
14 July 2006
Application Code
HSC06013
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Zelam Limited
PO Box 7142
New Plymouth
New Zealand
Applicant
Purpose of the Application
Experimental Pesticides: To import or manufacture substances in
containment to be used in contained field trials for the
purpose of researching the control of plant-damaging
organisms in various agricultural and horticultural crops.
(field trials)
Date Application Received
26 May 2006
Consideration Date
13 July 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 substances, ‘Code’
experimental pesticides, 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 (the Methodology).'
1.2
The substances have been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
‘Code’ experimental pesticides
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 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 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 26 May 2006.
3.2
Project Team:
Brendon Noonan
Application Advisor (Hazardous Substances)
Sue Scobie
Senior Science Adviser (Hazardous Substances)
Peter Jackson
Advisor, Maori Unit
Report review and sign-out by:
Noel McCardle
Senior Applications Advisor (Hazardous Substances)
3.3
The applicant supplied the following documents:
 the application
 a confidential appendix containing the proposed study and management plan,
information regarding containment and a sample of the trial protocol.
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 ‘Code’
experimental pesticides 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 HSNO Act).
4.2
In accordance with section 32 of the HSNO 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
ERMA New Zealand Decision: Application HSC06013
Page 2 of 12
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 HSNO Act.
Purpose of the Application
4.3
The purpose of the application is to import or manufacture in containment ‘Code’
experimental pesticides to be used in contained field trials for the purpose of
researching the control of plant-damaging organisms in various agricultural and
horticultural crops.
4.4
The application has been submitted to cover the manufacture and/or import of various
biologically and non-biologically active experimental crop protection agents for use in
routine field trials, with the intention that, under this approval, these trials will be
notified to ERMA New Zealand prior to their commencement and a new containment
application will not be required.
4.5
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
HSNO Act.
Life Cycle
4.6
Zelam Limited intends to manufacture or import a range of experimental pesticides
involving both biologically and non-biologically active components to be used in
contained field trials in New Zealand. The applicant has stated that where manufacture
is to occur in New Zealand it will be conducted in a Section 33 exempt laboratory1.
The applicant has stated that the quantity of each experimental pesticide to be
manufactured or imported will be sufficient for the trial(s) intended and will not exceed
100 litres or 100 kilograms.
4.7
The applicant has stated that each substance imported or manufactured will be
packaged in tamper proof packaging compliant with the requirements of the Hazardous
Substances (Packaging) Regulations 2001. Containers will be labelled in accordance
with the Hazardous Substance (Identification) Regulations 2001.
4.8
The substances will be stored securely in accordance with good practice, generally
through compliance with NZS8409 (Code of Practice for the Management of
Agrichemicals), at the manufacturing facility, the field trial sites and during transport.
4.9
During transport each shipment will be accompanied by a material safety data sheet
(MSDS). Import and transport will comply with the relevant legislation, for example,
the Land Transport Act 1998, and the Maritime Transport Act 1994.
4.10
The applicant has stated that field trials will conducted in accordance with their study
and management plans as submitted to the Agency as part of this application. The
study and management plans set out the requirements for establishing a trial site
including, identification of infestation of trial site by target pest species, arranging
1
The requirements for exempt laboratories are set out in the Hazardous Substances (Exempt Laboratories)
Regulations 2001.
ERMA New Zealand Decision: Application HSC06013
Page 3 of 12
permissions, establishment of trial boundaries and provisions to restrict access to the
trial site by persons and animals.
4.11
Preparation and application of the trial substances will be carried out by experienced
trained staff typically using purpose designed handheld pressure spray equipment.
Application will be carried out in accordance with good practice. Generally good
practice will be achieved by operation of the trial(s) in accordance with the Code of
Practice for the Management of Agrichemicals, NZS8409. The applicant has also
stated that where aerial application is required, prior approval will be sought.
4.12
Sample containers will be triple rinsed and the rinsate disposed of into a designated area
within the trial site. Any unused substance will either be disposed of onto a designated
area with in the trial site or be returned to Zelam Limited to be held in secure storage,
be destroyed or be exported from New Zealand.
Hazardous Properties
4.13
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.
4.14
The Agency also notes that the scope of the hazard information will often be limited, as
the substances will be experimental and may not be commercialised. Each substance
manufactured or imported under this approval will be notified to ERMA New Zealand
prior to its use, and the notification will include compositional information, a Project
Plan and a Safety Data Sheet and/or any available hazard information.
4.15
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
4.16
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
4.17
If released off target, the substances have the potential to result in adverse effects on the
environment.
4.18
On the basis of the lifecycle of the substances outlined in paragraphs 4.6-4.12, 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; or
ERMA New Zealand Decision: Application HSC06013
Page 4 of 12

4.19
failure to follow the correct operational procedures as set out in the controls,
management plan and project plans, resulting in release of the substances.
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. I consider that the controls in place are not too onerous to be
complied with and therefore the risks to the environment are negligible.
Risks to Human Health and Welfare
4.20
If the substances are ingested or inhaled, or come in contact with skin or eyes they have
the potential to cause adverse effects on human health.
4.21
On the basis of the lifecycle of the substances outlined in paragraph 4.6-4.12, 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; or
 failure to follow the correct operational procedures as set out in the controls,
management plan and project plans, resulting in release of the substances.
4.22
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. I consider that the controls in place are not too
onerous to be complied with and therefore the risks to human health and welfare are
negligible.
Māori issues and concerns
4.23
The Agency has considered the potential Māori cultural effects in accordance with the
Methodology clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO Act. In
addition, I have used the assessment framework contained in the ERMA New Zealand
User Guide “Working with Māori under the HSNO Act 1996” in assessing this
application.
4.24
The Agency has also noted that ‘Code’ experimental pesticides will have hazardous
properties that trigger several HSNO toxicity and ecotoxicity thresholds. There is the
potential that these substances could have a negative impact on Māori and the mauri of
iwi, cultural tāonga and the environment.
4.25
Having regard to the risks associated with these substances, I do not consider they will
have any significant impact on Māori culture or traditional relationships with ancestral
lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. I have no
evidence to suggest that the use of ‘Code’ experimental pesticides in containment will
breach the principles of the Treaty of Waitangi and see no requirement for the applicant
to consult with Māori regarding this application.
ERMA New Zealand Decision: Application HSC06013
Page 5 of 12
4.26
This assessment is made on the condition that the substances are handled, stored,
transported, used and disposed of, in accordance with the explicitly stated 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
recommended that the Trial Director 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 13);
 to exclude organisms from a facility (for example, control 11);
 to exclude unauthorized people from the facility (for example, control 10);
 to prevent unintended release of the substances by experimenters working with the
substance (for example, control 12);
 to control the effects of any accidental release of the substance (for example, control
22);
 inspection and monitoring requirements (for example, control 27); and
 qualifications required of the person responsible for implementing the controls (for
example, control 16).
5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, ‘Code’ experimental pesticides 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 ‘Code’ experimental
pesticides, 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 HSNO 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 HSNO Act and
regulations;
 clause 22 – the evaluation of risks – relevant considerations;
ERMA New Zealand Decision: Application HSC06013
Page 6 of 12

6.5
clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
The application to import into containment the hazardous substances ‘Code’
experimental pesticides is thus approved pursuant to section 32 of the HSNO Act,
with controls as set out in Appendix 1.
Rob Forlong
Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
‘Code’ experimental pesticides:
HSC000240
ERMA New Zealand Decision: Application HSC06013
Page 7 of 12
Appendix 1: List of controls that apply to the
hazardous substance, ‘Code’
experimental pesticides
1. Each substance imported or manufactured under this approval shall be notified in writing
to ERMA New Zealand prior to its use in a field trial. The notification shall include:
- a unique identifier for the substance;
- composition details;
- a Project Plan for the trials, containing information as specified in
Appendix 2;
- a Safety Data Sheet and/or any known hazard information; and
- the following identifying details:
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
HSC06013
HSC000240
Brendon Noonan
2. This approval will not apply to substances which trigger any hazardous property
thresholds in classes 1, 2, 3.2, 4 or 5.
3. This approval does not apply to substances that contain organisms or biologically active
ingredients that are “new organisms” as defined in section 2A of the HSNO Act.
4. Facilities used to manufacture and store substances under this approval shall be designed
and operated in accordance with the requirements of the Hazardous Substances (Exempt
Laboratories) Regulations 2001.
5. This approval applies only to the ground-based application of plant protection compounds
to agricultural and horticultural crops, to forestry and pastures, and to seeds. This
approval excludes any application of substances direct to water and any aerial application
of substances.
6. The trials shall be undertaken in accordance with the Management Plan which
accompanied the application, and the Project Plan which accompanies the notification of
each substance. Modifications to the Project Plan or Management Plan may only be
made with the prior written approval of ERMA New Zealand and must be in compliance
with the following controls.
7. 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
1.
8. The trial sites shall be chosen so as to prevent the substances entering any surface water
or groundwater system.
ERMA New Zealand Decision: Application HSC06013
Page 8 of 12
9. 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.
10. Access to the trial sites shall be by permission of the Trial Director2, or owner or occupier
of the property on which it is located. The trial site boundaries shall be clearly marked
and distinctly visible throughout the life of the trials. The trial site shall be signed
indicating that unauthorized access is not allowed, that the site is subject to an
experimental pesticide trial, and that the crops should not be removed or disturbed.
11. 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. In these situations, 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.
12. The substances shall be stored, mixed, diluted and prepared in any other way prior to
application in accordance with good practice. This may be demonstrated by 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.
13. 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.
14. The substances shall be transported in accordance with good practice and where
appropriate in compliance with the Land Transport Rule: Dangerous Goods 2005.
15. The substances applied to agricultural and horticultural crops, to forestry and to pastures
shall be applied by way of equipment calibrated to apply accurate doses to trial plots on
plots specifically designated and marked for each treatment, 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 8. Seed treatment applications shall be made following the Project Plan and using
suitable seed treatment apparatus. Treated seed shall be sown in a manner likely to
minimise exposure to birds. Where this is not possible, birds shall be actively deterred
from foraging on the trial site.
16. The personnel applying the substances to the crops shall be able to demonstrate that they
have the qualifications necessary to carry out the trial, for example, by holding
appropriate Growsafe certification or an Approved Handler qualification. They should
also be aware of the contents and requirements of the management plan and these
controls in order to adequately manage the substances.
2
The Trial Director is the individual appointed by the applicant, and named in the Project Plan as being
responsible for the overall conduct of the trial in accordance with the Management Plan and approval controls.
ERMA New Zealand Decision: Application HSC06013
Page 9 of 12
17. No sprayed produce shall be consumed by people or (so far as is reasonably practicable)
animals or 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.
18. 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 or by burial on the trial site or at an
approved landfill. The Trial Director shall decide the method of disposal after assessing
the relevant risks. Sprayed produce must not be diverted to any composting operation.
19. 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.
20. Any equipment used 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.
21. Surplus substances remaining at completion of the trials shall be returned to Zelam
Limited for secure storage in the original container(s), exported from New Zealand or
disposed of by destruction through a commercial chemical processor. (Completion is
defined as the end of the trial programme as specified in the Project Plan for each
substance. Once the trials are complete the substances do not have approval to be present
in New Zealand except in an exempt laboratory).
22. 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.
23. A record shall be kept of all use of the substances. 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.
24. 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 lifecycles. Safety glasses, gloves and protective clothing shall be worn when
handling the substances throughout their lifecycles.
25. The Department of Labour [Attn. HSNO Project Manager (Workplace Group) P O Box
3705, Wellington] shall be informed in writing (by letter, fax or email) of the location,
start, and completion of the trials. Notifications shall include the details specified in the
following table:
ERMA New Zealand Decision: Application HSC06013
Page 10 of 12
Substance name/code
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
HSC06013
HSC000240
Brendon Noonan
26. 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. If a breach in containment results in contamination of a waterway, it is
recommended that the relevant iwi authorities be advised.
27. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
28. This approval remains in force for five years from the date of this Decision.
29. The maximum total quantity of each experimental plant protection compound that shall
be manufactured or imported under this approval is 100 litres or 100 kg.
ERMA New Zealand Decision: Application HSC06013
Page 11 of 12
Appendix 2: Contents of Project Plan
The Project Plan to be supplied for each substance shall contain information on the following
points:
1) Direction, including identification of the Trial Director
2) Substance
3) Project title
4) Objectives
5) Locations
6) Plot size
7) Total treated area
8) Application method
9) Application period
10) Application rate
11) Protection of bees
12) For treated seeds, how risks to birds will be addressed
13) Disposal of treated produce
ERMA New Zealand Decision: Application HSC06013
Page 12 of 12