ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
06 October 2006
Application Code
HSC06019
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Applicant
DuPont (New Zealand) Limited
Wiri
Manukau City
New Zealand
Purpose of the Application
To import under containment experimental plant protection
compounds for the purpose of testing for the control of weed and
plant damaging organisms for the management of crop plants in
various agricultural, horticultural and forestry crops. (field trials)
Date Application Received
25 August 2006
Consideration Date
06 October 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to manufacture or import into containment the hazardous substances,
DuPont Experimental Plant Protection Compounds, 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:
DuPont Experimental Plant Protection Compounds [insert code]
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 25 August 2006.
3.2
Project Team:
Brendon Noonan
Advisor (Hazardous Substances)
Nicola Reeves
Advisor (Hazardous Substances)
Linda Robinson
General Manager, Māori Unit
Report review and sign-out by:
Beth Dye
Applications Manager (Hazardous Substances)
3.3
The applicant supplied the following documents:
 the application, setting out information provisions, a generic description of the likely
lifecycle and a list of proposed controls.
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 DuPont
Experimental Plant Protection Compounds 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
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.
ERMA New Zealand Decision: Application HSC06019
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Purpose of the Application
4.3
The purpose of the application is to gain approval for the contained manufacture or
importation, and field trialling of various experimental plant protection compounds.
The field trials are intended to generate data for the development of selected
compounds, but not necessarily for use in New Zealand.
4.4
As the purpose amounts to “research and development on any hazardous substance”,
the Agency considers that the application qualifies for consideration under section
30(ba) of the HSNO Act.
Substance description
4.5
The experimental plant protection compounds will contain biologically active
ingredients that are intended to control weeds, fungi, bacteria, insects and other plant
damaging organisms within various agricultural, horticultural and forestry crops.
Life Cycle
4.6
DuPont (New Zealand) Limited intend to manufacture or import a range of
experimental plant protection compounds containing biologically active ingredients to
generate information for the development of selected compounds. The total quantity of
each experimental substance will not exceed 100 L or 100 kg. Each experimental
substance will be imported fully packaged in HSNO and United Nations (UN)
compliant PET (polyethylene terephthalate) bottles, HDPE (high density polyethylene)
containers or other suitable containers.
4.7
The applicant has indicated that the substances will be transported in compliance with
the Land Transport Rule: Dangerous Goods 2005 and will be stored, handled and
applied in accordance with the Code of Practice for the Management of Agrichemicals
NZS8409. The applicant has also stated that trials shall be carried out in accordance
with the Project Plans supplied with each substance.
4.8
The experimental crop protection compounds are intended to be diluted in water before
being applied to small replicated plots using handheld operator worn equipment
powered by hydraulic pressure or compressed carbon dioxide. Trials are expected to be
run over a period of up to 10 years. The applicant has stipulated that the field trials will
be carried out on small-scale replicated plots that will be managed in accordance with
the specified containment provision.
4.9
Disposal of the substances will be carried out by returning unused substance to DuPont
for further analysis, storage, treatment or export. Waste from a spill, including any
absorbent material used in the clean up, will be sealed into containers and be disposed
of to an appropriate waste disposal facility. Surplus spray mix will be disposed of
within the trial sites by spraying on a designated non-crop area.
Hazardous Properties
4.10
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.
ERMA New Zealand Decision: Application HSC06019
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4.11
The Agency also notes that the scope of the hazard information will often be limited, as
the substances are likely to 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 including any available hazard information.
4.12
The applicant also considers that the substances covered under this approval will be
classified under the Hazardous Substances (Minimum Degrees of Hazard) Regulations
2001.
4.13
The Agency has taken the factors as described above into account in reviewing the
substances’ likely hazardous properties, and considers that the information is sufficient
to determine that any risks can be managed by the containment controls.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.14
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 Māori issues and concerns
as set out below:
Risks to the Environment
4.15
If released off target ie not within the defined application area, the substances have the
potential to cause adverse environmental effects.
4.16
On the basis of the lifecycle of the substances outlined in paragraphs 4.6-4.9, 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.
4.17
The Agency considers 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.
Risks to Human Health and Welfare
4.18
If the substances are ingested or inhaled, or come in contact with skin or eyes the
potential exists for adverse human health effects to occur.
4.19
On the basis of the lifecycle of the substances outlined in paragraph 4.6-4.9, 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.
ERMA New Zealand Decision: Application HSC06019
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4.20
The Agency considers that, taking into account the likely 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.
Māori issues and concerns
4.21
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.
4.22
The Agency has noted that DuPont Experimental Plant Protection Compounds are
likely to have hazardous properties that trigger various 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.
4.23
Having regard to the risks associated with these substances, the Agency does 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. The Agency has no evidence to suggest that the use of DuPont
Experimental Plant Protection Compounds 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.
4.24
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 9);
 to exclude organisms from a facility (for example, control 19);
 to exclude unauthorized people from the facility (for example, control 18);
 to prevent unintended release of the substances by experimenters working with the
substance (for example, control 22);
 to control the effects of any accidental release of the substance (for example, control
30);
 inspection and monitoring requirements (for example, control 35); and
ERMA New Zealand Decision: Application HSC06019
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
qualifications required of the person responsible for implementing the controls (for
example, control 21).
5.2
The Agency is satisfied that, with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, DuPont Experimental Plant Protection
Compounds can be adequately contained.
6
Decision
6.1
I have considered this application made under section 31 and, pursuant to section 32,
am satisfied that this application is for the purpose specified in section 30(ba) ie for
“research and development” .
6.2
Having considered the risks associated with the lifecycle of DuPont Experimental Plant
Protection Compounds, I am satisfied that the controls imposed, including those in
place under other legislation, will result in the substances being adequately contained.
Further, I consider that the controls imposed are not too onerous to be complied with.
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;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
6.5
The application to import into containment the hazardous substances DuPont
Experimental Plant Protection Compounds 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:
DuPont Experimental Plant Protection Compounds:
ERMA New Zealand Decision: Application HSC06019
HSC000247
Page 6 of 12
Appendix 1: List of controls that apply to the
hazardous substance, DuPont Experimental Plant
Protection Compounds
General requirements and restrictions
1. This approval covers the contained importation, manufacture and field trialling of
experimental plant protection compounds, as notified to ERMA New Zealand pursuant to
Control 5.
2. The maximum total quantity of each experimental plant protection compound that may be
manufactured or imported under this approval is 100 litres or 100 kg.
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 remains in place for five years from the date of this Decision.
5. 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
HSC06019
HSC000
Brendon Noonan
6. This approval does not apply to substances that trigger any hazardous property thresholds
in classes 1, 2, 3.2, 4 or 5.
7. This approval excludes application of substances directly into or onto water.
8. This approval excludes the aerial application of any substance.
Packaging and Information
9. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
10. Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001. The label must also set out instructions that any remaining substance
must be returned in its original container to DuPont (New Zealand) Limited for storage
and ultimately disposal.
ERMA New Zealand Decision: Application HSC06019
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11. A Safety Data Sheet, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each shipment and be held at the each trial site during
the period of the trial.
Storage
12. The substance shall be securely stored in accordance with good practice. This may be
demonstrated by compliance with the Code of Practice for the Management of
Agrichemicals NZS 8409: 2004.
Transport
13. The substance shall be transported in accordance with good practice and where
appropriate in compliance with any relevant requirements of the Land Transport Act
1998, the Civil Aviation Act 1990 or the Maritime Transport Act 1994.
General handling of the substances
14. Appropriate personal Protective Equipment (PPE), for example, safety glasses, gloves
and protective clothing shall be worn by persons handling the substance during
manufacture, use and disposal.
Trial site requirements
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 35.
16. The trial sites shall be chosen so as to prevent the substances 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 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 crops or plant matter should not be removed.
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. 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.
1
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of
the trial in accordance with that proposed in the application and the approval controls.
ERMA New Zealand Decision: Application HSC06019
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Trial conditions
20. The trials shall be undertaken in accordance with the information provided in the
application and the Project Plan which accompanies the notification of each substance.
Modifications to the Project Plan or information provided in the application may only be
made with the prior written approval of ERMA New Zealand and must be in compliance
with the controls specified in this document.
21. The personnel applying the substances 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. Experimental staff shall be
made aware of the study protocol and the controls in place in order to adequately manage
the substances.
22. The substances shall be mixed, diluted or be 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.
23. 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.
24. 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 18.
25. 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.
26. Seed treatment applications shall be made 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.
27. 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.
28. A record shall be kept of the 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.
ERMA New Zealand Decision: Application HSC06019
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29. 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 nongrazed area at the site, or alternatively within the trial plot.
Emergency Management
30. Any spillage of the substance (diluted or not) shall be contained, prevented from entering
water bodies, and absorbed with an appropriate absorbent material. The absorbent
material shall be placed in sealed containers and disposed of at an appropriate waste
disposal facility (which may include a landfill), subject to the facility’s waste acceptance
policy.
Disposal
31. Any surplus substance remaining at the ‘end of the trials’ shall be returned to DuPont
(New Zealand) Limited 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 completed the substance will not have approval to be present in
New Zealand except within an exempt laboratory).
32. 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.
33. 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.
34. 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 plant matter shall not be added into any composting
operation.
Notification and Inspection
35. 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/code
ERMA Application number
ERMA Approval number
ERMA Advisor (Hazardous Substances)
ERMA New Zealand Decision: Application HSC06019
DuPont Experimental Plant Protection
Compound [enter code]
HSC06019
HSC000
Brendon Noonan
Page 10 of 12
36. 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
waterbody, the relevant iwi authorities be advised.
37. 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 5, notwithstanding its confidential nature, shall be available for
inspection by any enforcement officer, upon request.
ERMA New Zealand Decision: Application HSC06019
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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 HSC06019
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