ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
25 September 2003
Application Code
HSC03007
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
Syngenta Crop Protection Ltd
Purpose of the Application
To import into containment fungicidal compounds of the
chemical class of Heterocyclic Amides (OPA)
formulated in a standard way. The intention is to
conduct small scale contained field trials to provide
information for development of these compounds.
Date Application Received
8 August 2003
Consideration Date
25 September 2003
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substances OPA1, OPA2,
OPA3, OPA4, OPA5, OPA6, OPA7, OPA8, OPA9, OPA10 and OPA11 is approved
with controls in accordance with the relevant provisions of the Hazardous Substances
and New Organisms (HSNO) Act 1996 and the HSNO (Methodology) Order 1998.
1.2
The substances have been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
OPA1
OPA2
OPA3
OPA4
OPA5
OPA6
OPA7
OPA8
OPA9
OPA10
OPA11
ERMA New Zealand Decision: Application HSC03007
Page 1 of 10
1.3
ERMA New Zealand has adopted the European Union use classification system as the
basis for recording the nature and uses of substances. The following use categories are
recorded for these substances:
Main category
Industry category
Function/use category
3
1
38
Non-dispersive use
Agricultural Industry
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 relevant to the purpose of the Act, as 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 Hazardous
Substances and New Organisms (Methodology) Order 1998 (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 8 August 2003 and verified as having
sufficient information on 19 August 2003.
3.2
The Project Team consisted of Susan Robertson (Applications Advisor) and Sur
Thomas (Senior Advisor (Toxicology)).
3.3
The applicant supplied the following documents:
 The application
 A confidential appendix, containing (1) specifications, compositions and Material
Safety Data Sheets (MSDSs) for the substances and their components, (2) a field
work protocol, and (3) a document entitled ‘HSE Guidance for Field Trials Staff
Working with Experimental and Registered Products’.
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 (Occupational Safety and Health)
The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
ERMA New Zealand Decision: Application HSC03007
Page 2 of 10
3.5
A response was received from the Public Health Directorate of the Ministry of Health,
asking about ERMA New Zealand’s processing of toxicological information where a
‘greater than’ value is available but where no upper cut-off value exists. A response
was provided to the Ministry of Health which advised that a toxicological threshold
would not be triggered in these cases, and that, in setting containment controls, ERMA
New Zealand would consider all uncertainties such as absences of sound toxicological
data.
3.6
The applicant was provided with a copy of the proposed controls for OPA1, OPA2,
OPA3, OPA4, OPA5, OPA6, OPA7, OPA8, OPA9, OPA10 and OPA11 and given the
opportunity to comment on them. The applicant’s comments have been considered
during my consideration of this application and the controls that should apply.
3.7
The ERMA New Zealand Senior Advisor (Māori Affairs) was advised of the
application. Her comments form the basis of paragraphs 4.26, 4.27 and 4.28 of this
decision.
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 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
substances could be adequately contained by controls to provide for each of the matters
specified in Part III of the Third Schedule of the Act.
Purpose of the Application
4.3
The purpose of the application is to import the substances OPA1, OPA2, OPA3, OPA4,
OPA5, OPA6, OPA7, OPA8, OPA9, OPA10 and OPA11, in order to conduct field trials
to determine the efficacy profile of these products as fungicides for wheat crops.
4.4
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 Act.
Hazard Properties
4.5
I note 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 HSC03007
Page 3 of 10
4.6
OPA1, OPA2, OPA3, OPA4, OPA5, OPA6, OPA7, OPA8, OPA9, OPA10 and OPA11
are variants of heterocyclic amides.
4.7
The applicant has advised that OPA1, OPA2, OPA3, OPA4, OPA5, OPA6, OPA7,
OPA8, OPA9, OPA10 and OPA11 are novel compounds that have not previously been
registered as pesticides in New Zealand, although similar active ingredients are
registered or under assessment in the European Union and USA (EPA). As such, there
is some uncertainty in the hazardous properties of these substances.
4.8
The applicant has assessed the available information and has identified that the active
ingredient in OPA1, OPA2, OPA3, OPA4, OPA5, OPA6, OPA7, OPA8, OPA9, OPA10
and OPA11 has aquatic ecotoxicity properties, and that other properties of the active
ingredient are either unknown or not triggered.
4.9
The applicant states that little data is available on the toxicological and ecotoxicological
properties of the formulated substances, and that the information contained in the
MSDSs for the components and for the substances strongly suggests that the active
ingredient is the only critical component in these substances.
4.10
I have reviewed the applicant’s hazard information and consider that it is sufficient to
describe the hazards associated with the substances to ensure that any risks can be
managed by the containment controls.
Life Cycle
4.11
The substances, OPA1, OPA2, OPA3, OPA4, OPA5, OPA6, OPA7, OPA8, OPA9,
OPA10 and OPA11, will be manufactured in Switzerland.
4.12
Syngenta Crop Protection Ltd plans to import up to 0.1 L of each substance. The
substances will arrive in New Zealand in PET bottles, where they will be stored by
Syngenta Crop Protection Ltd in suitable facilities, prior to being transported to the
personnel conducting the trials.
4.13
The substances will then be dispensed into spray mix quantities and transported to the
trial sites, where the spray mixture will be prepared.
4.14
Each substance will be diluted prior to use (spray volume 200 – 300 L/ha) and applied
by way of hand-held spray-boom application equipment, using hydraulic pressure or
compressed CO2 or air on plots specifically designated and marked for each treatment.
4.15
The trials will take place on small wheat plots, in sites within commercial facilities.
Each trial site, containing 1-2 trials, will be a maximum of 0.12 hectares. The trial
season runs from September to March, and it is expected that trials will need to be
continued over two trial seasons.
ERMA New Zealand Decision: Application HSC03007
Page 4 of 10
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.16
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential
risks of escape from containment under the headings of environmental, human health
and welfare and Māori issues and concerns.
4.17
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of, risk management.
Risks to the Environment
4.18
If released into waterways, the substances have the potential to result in adverse effects
on aquatic organisms.
4.19
On the basis of the lifecycle of the substances outlined in paragraph 4.11 to 4.15, effects
on aquatic organisms could arise from:


An accident during storage, mixing, use or transportation, resulting in release of the
substances into waterways
Failure to follow correct use and disposal procedures.
4.20
I note that some of the ecotoxicological properties of these substances are unknown
given their stage of development and testing.
4.21
I consider that, taking into account the properties of the substances, the quantities
involved, the containment regime specified in the controls on this approval, industry
codes of practice to be used and any controls in place under other legislation (such as
the Land Transfer Rule: Dangerous Goods 1999), there are no significant risks to the
environment.
Risks to Human Health and Welfare
4.22
The applicant has noted that these substances have not been tested for all toxicological
thresholds.
4.23
In taking a precautionary approach, I have assumed that the substances will trigger at
least one of the toxic thresholds.
4.24
On the basis of the lifecycle of the substances outlined in paragraph 4.11 to 4.15, effects
on human health and welfare may arise from:


An accident during storage, mixing, use or transportation, resulting in exposure to
the substances
Failure to follow correct use and disposal procedures.
ERMA New Zealand Decision: Application HSC03007
Page 5 of 10
4.25
I consider that, taking into account the properties of the substances, the quantity
involved, the containment regime specified in the controls on this approval, industry
codes of practice to be used and controls in place under other legislation (such as the
Health and Safety in Employment Act), there are no significant risks to human health
and welfare.
Māori issues and concerns
4.26
I have considered the potential Māori cultural effects of this application in accordance
with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework
contained in the ERMA New Zealand User Guide “Working with Māori under the
HSNO Act 1996”.
4.27
On the basis of the information provided by the ERMA New Zealand Senior Advisor
(Māori Affairs), including consideration of the very small quantities of the substances
that are to be imported, I consider that the substances are unlikely to have an impact on
the relationship of Māori and their culture and traditions with their ancestral lands,
water, sites, waahi tapu, valued flora and fauna and other taonga, and I consider that
there is no requirement for the applicant to consult with Maori regarding this
application. This is on the condition that the substances are used in accordance with the
controls in Appendix 1, and in accordance with any other relevant controls applying
under other legislation and industry codes of practice.
4.28
However, should inappropriate or accidental use, transport or disposal of any substance
result in the contamination of waterways, it is suggested that the applicant notify the
appropriate authorities including the relevant iwi authorities in the region.
5
Containment and Controls
5.1
I have evaluated the adequacy of the containment arrangements of the applicant and the
controls listed in Appendix 1, and note that these cover the matters set out in Part III of
the Third Schedule of the Act, being







5.2
To limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances.
To exclude organisms from a facility.
To exclude unauthorized people from the facility.
To prevent unintended release of the substances by experimenters working with the
substances.
To control the effects of any accidental release of the substances.
Inspection and monitoring requirements.
Qualifications required of the person responsible for implementing the controls.
Controls listed in Appendix 1 will prevent exposure to the substances (such as providing
an adequate buffer zone between the trial and any buildings nearby), thereby mitigating
the likelihood of adverse effects on the human population that could arise from any
unidentified toxic properties.
ERMA New Zealand Decision: Application HSC03007
Page 6 of 10
5.3
Controls listed in Appendix 1 will ensure that the substances do not enter waterways,
thereby mitigating the likelihood of adverse effects on aquatic organisms. They will
also mitigate the likelihood of adverse effects on the environment that could arise from
any unidentified ecotoxicological properties.
5.4
Additional controls are in place to protect the security of the trial facilities and the
integrity of the trial, and to ensure appropriate management of the trial facilities.
5.5
Therefore, I am satisfied that with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, the substances can be adequately
contained.
6
Decision
6.1
I have considered this application under section 31 to import into containment the
hazardous substances OPA1, OPA2, OPA3, OPA4, OPA5, OPA6, OPA7, OPA8,
OPA9, OPA10 and OPA11, 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 the substances, 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 Act.
6.4
I have also applied the following criteria in the Methodology:





6.5
clause 9 – equivalent of sections 5, 6 and 8;
clause 11 – characteristics of substances;
clause 21 – the decision accords with the requirements of the Act and regulations;
clause 22 – the evaluation of risks – relevant considerations;
clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
The application to import into containment the hazardous substances OPA1, OPA2,
OPA3, OPA4, OPA5, OPA6, OPA7, OPA8, OPA9, OPA10 and OPA11 is thus
approved pursuant to section 31 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
OPA1
OPA2
OPA3
OPA4
OPA5
ERMA New Zealand Decision: Application HSC03007
HSC000054
HSC000057
HSC000058
HSC000059
HSC000060
OPA6
OPA7
OPA8
OPA9
OPA10
OPA11
HSC000061
HSC000062
HSC000063
HSC000064
HSC000055
HSC000056
Page 7 of 10
Appendix 1: List of controls that apply to the
hazardous substances OPA1, OPA2, OPA3, OPA4,
OPA5, OPA6, OPA7, OPA8, OPA9, OPA10 and OPA11
1. The trials shall be undertaken in accordance with the information contained within the
application and attached field protocol.
2. Notwithstanding the requirements of control 1 above, the trials shall comply with
controls 3 to 26 below.
3. The maximum quantity of each substance that shall be imported is 0.1 litres (100 mL).
4. The trials may be carried out at a location that is not defined, provided the applicant;
 has permission from the owner of the land to carry out the trial.
 notifies ERMA New Zealand of the locations as per control 21.
5. The trial sites shall be chosen so as to prevent any of the substances entering any surface
water or groundwater system.
6. Trial sites shall be located to prevent any building where people live or work being
exposed to the substance.
7. 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 primary
access points shall be signed indicating that unauthorized access is not allowed, that the
site is subject to a trial, and that the crops should not be removed or disturbed.
8. The substances shall be imported and stored in accordance with the Code of Practice for
the Management of Agrichemicals NZS8409:1999.
9. The substances shall be securely packed and stored 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.
10. The transportation of the substances shall comply with any requirements under the Land
Transport Rule: Dangerous Goods 1999.
11. The substances shall be applied by way of hand-held/operator-worn equipment, using
hydraulic pressure or compressed CO2 or air 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.
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 trial protocols and approval controls.
ERMA New Zealand Decision: Application HSC03007
Page 8 of 10
12. The personnel applying the substances to the crops shall be able to demonstrate that they
have the qualifications necessary to carry out the trial. One way of demonstrating this
would be the holding of appropriate Growsafe certification.
13. Special attention shall be paid to the avoidance of drift beyond the boundary of the trial
sites. Sufficient buffer zones must be maintained to ensure that commercial produce does
not come into contact with the substances.
14. No produce from within the trial site (including the buffer zone) shall be consumed by
people or animals or offered for sale.
15. Produce from within the trial site (including the buffer zone) shall be disposed of by
ploughing in, by mulching or by burial at an approved landfill (not to be diverted to any
composting operation).
16. The amount of spray prepared shall be adequate for the trial site, but if there is any
surplus spray mix it shall be disposed of within the trial site by being further diluted and
sprayed over a marked and designated non-crop and non-grazed area within the trial site.
17. The equipment used shall be rinsed after use with the appropriate detergent or
decontaminant, and rinsate disposed of within the trial site by being sprayed over a
marked and designated non-crop and non-grazed area within the trial site.
18. Surplus substances remaining at the end of the trials shall be returned to Syngenta Crop
Protection Ltd for secure storage in an exempt laboratory, exported or degraded to a nonhazardous substance. (Note that once the trials are complete the substances do not have
an approval to be present in New Zealand except in an exempt laboratory).
19. Any accidental spillage of the unmixed substances or spray mixes shall be diluted with
water, sand or earth, and then spread over a marked and designated non-crop and nongrazed area within the trial site.
20. A record shall be kept of all use of the substances. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Class 6, 8 and 9 Controls)
Regulations.
21. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
location, start, and completion of the trials, at least three working days prior to
commencement of the trials. The OSH project manager shall be informed at least three
working days prior to application at specific sites. Notification can be by fax or e-mail.
22. Information of the appropriate safety precautions necessary to provide safeguards against
the substances’ ecotoxic properties shall accompany each substance at all stages of its
lifecycle. This shall include information on the appropriate protective clothing that is to
be used.
23. Information on the relevant first aid measures for immediate action pending medical
attention shall accompany the substances at all stages of their lifecycle.
ERMA New Zealand Decision: Application HSC03007
Page 9 of 10
24. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
25. If for any reason a breach of containment occurs, the Trial Director shall notify OSH and
ERMA New Zealand within 24 hours of the breach being detected.
26. This approval expires on 31 August 2005.
ERMA New Zealand Decision: Application HSC03007
Page 10 of 10