ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
17 January 2008
Application Code
HSC07039
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
Agrivet Services Limited
Purpose of the Application
Agrivet07 – Experimental Plant Protection Compounds: To import
into containment experimental plant protection compounds for use in
field trials (generic).
Date Application Received
22 November 2007
Consideration Date
17 January 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to import into containment hazardous substances described as,
Agrivet07 – Experimental Plant Protection Compounds, is approved with
controls in accordance with the relevant provisions of 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:
Agrivet07 – Experimental Plant Protection Compounds
2 Application process
2.1
The application was formally received on 22 November 2007.
2.2
Project Team:
Elizabeth Morgan
Sekove Tinalevu
Zack Bishara
Noel McCardle
Beth Dye
2.3
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Māori Unit)
Senior Advisor (Hazardous Substances).
Applications Manager
The applicant supplied the following documents:


the application, and
a confidential appendix, including a draft containment plan.
2.4
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:

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The Ministry of Health;
The Department of Labour (Workplace Group);
The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
2.5
No responses were received.
2.6
The applicant was provided with a copy of the proposed controls for Agrivet07 –
Experimental Plant Protection Compounds and given the opportunity to
comment on them. The applicant’s comments were taken into consideration in
finalising the controls.
3 Consideration
Purpose of the application
3.1
The purpose of this application is to import plant protection substances for
experimental use in containment trials to provide information for research and
development of selected substances. The field trials are proposed to take place
over five years. The applicant advises that the substances to be trialed will
contain biologically active ingredient/s, which may be experimental and are
unlikely to have been commercialised elsewhere. The applicant considers that it
is likely the substances will be hazardous under the Act.
3.2
The plant protection substances will consist of insecticides, herbicides,
fungicides, plant growth regulators and other plant protection substances. These
will be applied to trial sites and individual test plots by ground application
methods or by seed/plant treatment.
3.3
The Project Team considers that the purpose stated by the applicant amounts to
“research and development on any hazardous substance” and therefore qualifies
for consideration under section 30(ba).
Lifecycle
3.4
The applicant advises that the substances will be dealt with throughout their
lifecycles in New Zealand in the following manner:
Importation and transport
3.4.1 The volume of the new substances involved in the plant studies is expected
to be  20 litres/kg per substance per season. This equates to a total
expected quantity of trial substances of  100 litres (kg) per substance for
the five-year period of the trial.
3.4.2 The substances will be manufactured overseas and imported into New
Zealand. They will arrive in appropriate packaging suitable for shipment to
and within New Zealand.
ERMA New Zealand Decision: Application HSC07039
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3.4.3 It is intended to evaluate these substances in containment trials primarily
on the applicant’s site in Hawke’s Bay but they may also be used in other
regions of New Zealand.
3.4.4 Small volumes (likely 1 litre) will be transported by specialist carriers
and used at any one time.
Storage
3.4.5 The substances will be stored in a secure facility that is suitable for the
storage of substances of this type and which has in place all the
appropriate procedures and documentation to effectively manage any
possible risks to the environment and to those handling the product.
Application of the substances
3.4.6 Preparation and application of the trial substances will be carried out by
experienced trained staff. Small amounts of the substances will be applied
to small areas with precision equipment (e.g. backpack sprayers).
Disposal of surplus substance
3.4.7 Surplus substance will be returned to the supplier, otherwise another
suitable disposal method will be employed to render the substance nonhazardous when discharged into the environment.
4 Hazardous properties
4.1
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.
4.2
It is also noted that the scope of the hazard information will often be limited, as
the substances will be experimental and may not be commercialised. Each
substance imported under this approval will be notified to ERMA New Zealand
prior to its trialling, and the notification will include compositional information,
a Project Plan and a Safety Data Sheet and any available hazard information.
4.3
The applicant expects that some of the substances involved will have hazardous
properties that trigger the minimum degrees of hazard for each allowable hazard
category, as defined in the Hazardous Substances (Minimum Degrees of Hazard)
Regulations 2001 and as limited in Appendix 1.
4.4
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
4.5
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:
ERMA New Zealand Decision: Application HSC07039
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Risks to the environment
4.6
The Project Team considers that, if released or discharged into the environment,
the substances have the potential to result in adverse effects within the
environment. As the ecotoxic hazards are not identified at this stage, the Project
Team assumes that the substances could cause adverse effects within the aquatic,
soil, or above-ground terrestrial environments.
4.7
On the basis of the lifecycle of the substances outlined in paragraph 3.4, adverse
effects could arise from:



an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the
management plan.
4.8
The applicant has specified containment provisions intended to manage these
risks.
4.9
The Project Team considers that, taking into account the likely properties of the
substances, the quantities involved, the containment regime proposed by the
applicant, the controls set in Appendix 1 and in place under other legislation,
there are no significant risks to the environment.
Risks to human health
4.10
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.
4.11
On the basis of the lifecycle of the substances outlined in paragraph 3.4, adverse
effects could arise from:



4.12
an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the
management plan.
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, the Project Team
considers there are no significant risks to human health and welfare.
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Māori issues and concerns
4.13
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”.
4.14
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 substances are used in accordance with the HSNO
controls established for this application, and in accordance with any other
relevant controls applying under other legislation.
4.15
In addition, the trial of these substances does not involve significant community
exposure or significant exposure to the environment. The Project Team
therefore considers that there is no requirement for the applicant to consult with
Māori regarding this application.
4.16
However, should inappropriate or accidental use, transport or disposal of the
substances result in the contamination of waterways, it is suggested that the
applicant 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:

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



to limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances (for example, control 8);
to exclude organisms from a facility (for example, control 18);
to exclude unauthorized people from the facility (for example, control 17);
to prevent unintended release of the substances by experimenters working
with the substance (for example, control 21);
to control the effects of any accidental release of the substance (for
example, control 25);
inspection and monitoring requirements (for example, control 33); and
qualifications required of the person responsible for implementing the
controls (for example, control 20).
6 Conclusion
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), namely research and development on any hazardous substance.
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6.2
Having considered the risks associated with the lifecycle of Agrivet07 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.
6.3
The application to import into containment the hazardous substance Agrivet07 Experimental Plant Protection Compounds is thus approved with controls in
accordance with the relevant provisions of the Act and the Methodology as more
specifically set out in Appendix 2.
signed
Rob Forlong
Date: 17 January 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC07039
HSC000307
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APPENDIX 1.1: LIST OF CONTROLS THAT APPLY
TO AGRIVET07 - EXPERIMENTAL PLANT
PROTECTION COMPOUNDS
General requirements and restrictions
1.
This approval covers the contained importation, manufacture and trialling of
experimental plant protection compounds, as notified to ERMA New Zealand
pursuant to Control 6.
2.
This approval applies exclusively and is limited to substances being studied by
or on behalf of Agrivet Services Ltd.
3.
The maximum total quantity of each plant protection substance that may be
manufactured or imported under this approval is 100 kg or 100L.
4.
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.
5.
This approval remains in place for five years from the date of this decision.
6.
Each substance imported 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
trial. The notification shall include:
composition details;
a Project Plan for the trial, containing information as specified in
Appendix 1.2;
a Safety Data Sheet and/or any known hazard information; and
the following identifying details:
7.
ERMA Application number
HSC07039
Substance name/code
Agrivet07 – Experimental Plant Protection
Compounds
ERMA Approval number
HSC000307
ERMA Applications Advisor
Elizabeth Morgan
This approval does not apply to substances that trigger any hazardous property
thresholds in classes 1, 2, 3.2, 4 or 5.
Packaging and information
8.
The substances shall be securely packed in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001.
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9.
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 Agrivet
Services Ltd. for storage and ultimately disposal.
10.
A Safety Data Sheet shall accompany any transported substances.
Storage
11.
The substances 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
12.
The substances 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 and the Maritime Transport Act 1994.
General handling of the substances
13.
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.
Trial site requirements
14.
The trials shall be carried out on Agrivet Services Ltd’s site or at a location that
is not defined prior to approval, provided Agrivet Services Ltd:
a.
has written permission from the owner of the land to carry out the trial; and
b.
notifies ERMA New Zealand in writing of the location in accordance with
Control 6.
15.
The trial sites shall be chosen so as to prevent the substances entering any
surface water or groundwater system.
16.
The trial sites shall be located to prevent any residential building or workplace
which is not related to the research from being exposed to the substances.
17.
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 duration
of the trials. The trial sites shall be signed indicating that unauthorised access is
not allowed, that the site is subject to an experimental pesticide trial, and that the
crops should not be removed or disturbed.
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 approval controls.
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18.
Trial sites that are at risk of entry by grazing animals shall be secured by stock
proof fencing to exclude animals for the duration of the trial. 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.
Trial conditions
19.
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.
20.
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. 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.
21.
The substances shall be mixed, diluted or prepared in any 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.
22.
Only the quantity of each substance that is sufficient for the trial work in the
study shall be taken to the study site. However, a pre-measured backup sample
of each treatment may be taken where a trial is some distance away from the
chemical storage site.
23.
The substances 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 17. 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.
24.
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.
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Emergency management
25.
Any spillage of a substance 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
26.
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.
27.
Any surplus substance remaining at the end of a trial2 shall be returned to
Agrivet Services Ltd. 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. (Note that once the trials are completed the substance will not have
approval to be present in New Zealand except within an exempt laboratory).
28.
Any surplus substance shall ultimately be treated in a manner to render the
substance, as a whole, non-hazardous or be exported from New Zealand.
Disposal shall be carried out in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001.
29.
Containers no longer used to contain the substance shall be disposed of in a
manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
30.
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.
31.
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.
32.
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.
2
The end of the trial is considered to be the end of the trial programme as defined in the project plan for each
substance.
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Notification and inspection
33.
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.
34.
Trial documentation, as described in Control 6, notwithstanding its confidential
nature, shall be available for inspection by any enforcement officer, upon
request.
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APPENDIX 1.2: 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) Disposal of treated produce
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APPENDIX 2: LEGISLATIVE CRITERIA FOR THE
APPROVAL
A2.1.
Unless otherwise stated, references to section numbers in this decision refer to
sections of the Act and references to clauses refer to clauses in the Methodology.
A2.2.
The application was lodged pursuant to section 31. The decision was made 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
(including the Methodology) and the provisions of Part III of the Third Schedule
of the Act.
A2.3.
Government departments with an interest in this type of application were
advised of the receipt of the application in accordance with clause 2(2)(e).
A2.4.
This application was considered by the Chief Executive of ERMA New Zealand
under delegation from the Authority (section 19(2)(e)).
A2.5.
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 (Clauses 9, 12, 13, 14, 22,
24, 25) 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.
A2.6.
In accordance with clause 36(2)(b), it is recorded that, in reaching his decision,
the Chief Executive applied the criteria specified in section 32.
A2.7.
The Chief Executive also applied the following criteria in the Methodology:

clause 11 – characteristics of substance;

clause 21 – the decision accords with the requirements of the Act and
regulations;

clause 26 – all risks negligible;

clause 35 – the costs and benefits of the controls.
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