ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
5 October 2007
Application Code
HSC07021
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous Substances
and New Organisms Act 1996
Applicant
Nufarm Ltd
PO Box 22-407
Auckland
New Zealand
Purpose of the Application
To import or manufacture experimental agricultural
chemicals in containment for the purposes of testing for the
control of weeds, pests or diseases or for the management of
crop production in agricultural, horticultural and forestry
sectors.
Date Application Received
30 July 2007
Consideration Date
4 October 2007
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, Nufarm
Experimental Agricultural Compounds [code], is approved with controls in
accordance with the relevant provisions of the Hazardous Substances and New
Organisms Act 1996 (“the 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:
Nufarm Experimental Agricultural Compounds [code]
2 Legislative criteria for the 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.
3 Application process
3.3
3.1
The application was formally received on 30 July 2007.
3.2
Project Team:
Haydn Murdoch
Advisor (Hazardous Substances)
Sekove Tinalevu
Advisor (Hazardous Substances)
Linda Faulkner
General Manager, Maori Unit
Noel McCardle
Senior Advisor (Hazardous Substances).
The applicant supplied the following documents:
 the application;
 a confidential appendix containing the trial management plans for both field and
laboratory based trials.
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 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
Further information was requested from the applicant during the evaluation and review
of this application in accordance with section 58 and consequently the consideration
was postponed for 10 working days.
3.7
Due to delays in the evaluation and review of this application, the Authority, with the
applicant’s consent, waived the requirement to consider this application 30 working
days after formal receipt for a further 8 working days.
3.8
The applicant was provided with a copy of the proposed controls for Nufarm
Experimental Agricultural Compounds [code] and given the opportunity to comment on
them. The comments provided were taken into account in the setting of controls.
ERMA New Zealand Decision: Application HSC07021
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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 HSNO Act.
Purpose of the application
4.3
The purpose of the application is to import or manufacture in containment Nufarm
Experimental Agricultural Compounds [code] to be used in contained field and
laboratory 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 and laboratory 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”, the Project Team considers that the application qualifies for
consideration under section 30(ba).
Lifecycle
4.6
Nufarm Ltd intends to manufacture or import a range of experimental pesticides
involving both biologically and non-biologically active components to be used in
contained field and laboratory trials in New Zealand. 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 packaging compliant with the requirements of the Hazardous
Substances (Packaging) Regulations 2001. Containers will be labelled in
accordance with the Hazardous Substances (Identification) Regulations 2001.
4.8
The applicant has stated that the storage facilities will be under the control of the
Study Director, Principal Investigators or Laboratory Manager and be secure with
only authorised persons having access. The storage facility will be a secure
structure (lockable building or cupboard), within which the substance is stored in
sealed containers. All legal requirements for storage will be met. The test substance
will be stored in sealed containers at the Nufarm NZ Auckland, Hamilton or
ERMA New Zealand Decision: Application HSC07021
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Christchurch storage facilities and in sealed containers at facilities under the control
of a Principal Investigator.
4.9
Transport within New Zealand to the Principal Investigators, Field Researchers and
the test facilities will be provided by transport companies (road or containerised sea
transport) or by private vehicle in sealed containers with labels and documentation
that comply with the relevant transport and HSNO controls. A Safety Data Sheet
(SDS) shall be included with each shipment. A copy of the Chain of Custody
record shall be included with each shipment.
4.10
The applicant has stated that the trials will conducted in accordance with their trail
management plans for field and laboratory based trials, as submitted to ERMA New
Zealand as part of this application. The trial management plans set out the
responsibilities of key personnel, the requirements for reporting of results, sample
management, site management and health and safety responsibilities.
4.11
Preparation and application of the trial substances will be carried out by
experienced trained staff. Substances may be applied in a number of ways
including hand held application equipment, boom or air-blast sprayers, weed wipers
or mechanical sprayers. 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, NZS
8409:2004. The substances will be applied onto plots specifically designated and
marked for each treatment. The applicant has also stated that where aerial
application is required, additional approval will be sought from ERMA New
Zealand.
4.12
All surplus samples will be held in original containers and stored at Nufarm Ltd
facilities in an exempt laboratory until after such time as the product is registered
for use.
Hazardous properties
4.13
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.
4.14
The Project Team 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
The applicant expects that some of the substances involved are likely to have
hazardous properties that exceed the minimum degrees of hazard for each allowable
hazard category, as defined the Hazardous Substances (Minimum Degrees of
Hazard) Regulations 2001 and as limited in Appendix 1.
ERMA New Zealand Decision: Application HSC07021
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4.16
After taking into account the substances’ potential hazardous properties, the Project
Team considers that the information provided is sufficient to determine that any
risks can be managed by the containment controls proposed in Appendix 1.
Identification and evaluation of the significant risks of the substances in
containment
4.17
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
4.18
If released off target, the substances have the potential to result in adverse effects
on the environment.
4.19
On the basis of the lifecycle of the substances outlined in paragraphs 4.6-4.12,
adverse effects could arise from:
o an accident during storage, use or transportation, resulting in release of the
substances;
o failure to follow correct disposal procedures as outlined in the management
plan; or
o failure to follow the correct operational procedures as set out in the controls,
management plan and project plans, resulting in release of the substances.
4.20
The Project Team 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. The Project Team
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
4.21
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.
4.22
On the basis of the lifecycle of the substances outlined in paragraph 4.6-4.12,
adverse effects could arise from:
o an accident during storage, use or transportation, resulting in release of the
substances;
o failure to follow correct disposal procedures as outlined in the management
plan; or
o 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 HSC07021
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4.23
The Project Team 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 human health and welfare. The Project
Team considers 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
4.24
The Project Team considered the potential Māori cultural effects of this application
in accordance with sections 6(d) and 8, and the assessment framework contained in
the ERMA New Zealand User Guide “Working with Māori under the HSNO Act
1996”.
4.25
From the information provided, and considering that the application is for
containment, the Project Team considers that it is unlikely to have an impact on the
relationship between Māori culture and their traditions with their ancestral lands,
water, sites, waahi tapu, valued flora and fauna and other taonga. This is on the
condition that the substance is used in accordance with the trial management plans,
HSNO controls established for this application, and in accordance with any other
relevant controls applying under other legislation.
4.26
The Project Team has no evidence to suggest that the use of Nufarm Experimental
Agricultural Compounds [code] in containment will breach the principles of the
Treaty of Waitangi.
4.27
The Project Team therefore considers that there is no requirement for the applicant
to consult with Māori regarding this application. However, should inappropriate or
accidental use, transport or disposal of the substance result in the contamination of
waterways, it is suggested that the Study Director notify the appropriate authorities
including the relevant iwi authorities in the region. This action should include
advising them of the contamination and the measures taken in response.
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:
o to limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances (for example, control 12);
o to exclude organisms from a facility (for example, control 10);
o to exclude unauthorized people from the facility (for example, control 9);
o to prevent unintended release of the substances by experimenters working
with the substance (for example, control 11);
o to control the effects of any accidental release of the substance (for example,
control 21);
o inspection and monitoring requirements (for example, control 25); and
o qualifications required of the person responsible for implementing the
controls (for example, control 15).
ERMA New Zealand Decision: Application HSC07021
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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, Nufarm Experimental
Agricultural Compounds [code] 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 Nufarm Experimental
Agricultural Compounds [code], 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.
6.4
I have also applied the following criteria in the Methodology:
o clause 9 – equivalent of sections 5, 6 and 8;
o clause 11 – characteristics of substances;
o clause 21 – the decision accords with the requirements of the HSNO Act and
regulations;
o clause 22 – the evaluation of risks – relevant considerations;
o clause 24 – the use of recognised risk identification, assessment, evaluation
and management techniques.
6.5
The application to import into containment the hazardous substances Nufarm
Experimental Agricultural Compounds [code] is thus approved pursuant to section
32, with controls as set out in Appendix 1.
Signed
Rob Forlong
Chief Executive of ERMA New Zealand
5 October 2007
Date
Nufarm Experimental Agricultural Compounds [code]
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC07021
HSC000289
Page 7 of 12
Appendix 1:
List of controls that apply to the hazardous substances,
Nufarm Experimental Agricultural Compounds [code]
1. Each substance imported or manufactured under this approval shall be notified in writing
to ERMA New Zealand and The Department of Labour [Attn. HSNO Project Manager
(Workplace Group) or equivalent position] prior to its use in a field or laboratory trial.
The notification shall include:
-
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
Substance name/code
ERMA Approval number
ERMA Applications Advisor
HSC07021
Nufarm Experimental Agricultural Compound
[code]
HSC000289
Haydn Murdoch
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.
4. 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.
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 Trial Management Plans 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 trial sites shall be chosen so as to prevent the substances entering any surface water
or groundwater system.
8. 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.
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9. Access to the trial sites shall be by permission of the Study Director1, 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.
10. 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.
11. 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 NZS 8409:2004 or a
Standard Operating Procedure retained as part of the applicant’s trial records.
12. 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 any transported substances.
13. The substances shall be transported in accordance with good practice and in compliance
with the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport
Act 1994 (as applicable).
14. 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 NZS 8409:2004 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 9. 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.
15. 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 Trial Management Plans and these
controls in order to adequately manage the substances.
1
The Study 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 Trial Management Plan and approval
controls.
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16. 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.
17. 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 Study Director shall decide the method of disposal after assessing
the relevant risks. Sprayed produce must not be diverted to any composting operation.
18. 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.
19. 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.
20. Surplus substances remaining at completion of the trials shall be returned to Nufarm
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).
21. 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.
22. 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 (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.
23. 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.
24. If for any reason a breach of containment occurs, the Study 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.
ERMA New Zealand Decision: Application HSC07021
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25. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
26. This approval remains in force for five years from the date of this decision.
27. 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 HSC07021
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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 Study 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
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