ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
17 February 2006
Application Code
HSC06001
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Taranaki NuChem Limited
P O Box 7142
Purpose of the Application
New Plymouth
Tnl 1146: to manufacture the substance Tnl 1146 to
conduct field trials to evaluate whether the substance is
suitable for use in New Zealand agriculture and
horticulture (field trial).
Date Application Received
16 January 2006
Consideration Date
17 February 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to manufacture into containment the hazardous substance Tnl 1146 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 substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
Tnl 1146
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 HSNO 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 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 16 January 2006.
3.2
Project Team:
Emma Doust
Applications Advisor (Hazardous Substances)
Sue Scobie
Senior Science Advisor (Hazardous Substances)
Peter Jackson
Advisor (Māori Unit)
Report review and sign-out by:
Noel McCardle
Applications Team Leader (Hazardous
Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices including formulation details, Management plans and
MSDSs.
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
Responses were received from:
 the Ministry of Health stating that “with appropriate HSNO controls, the
Ministry has no issues to raise at this time relating to the acceptance of this
application based on non-confidential information provided from a public
health perspective (non-occupational)”.
 The ACVM Group stating that “as this application will be considered under the
ACVM Act, any issues which may arise under the Acts administered by
MAF/NZFSA will be considered as part of that application”.
3.6
The applicant was provided with a copy of the proposed controls for Tnl 1146 and
given the opportunity to comment on them. The comments received from the applicant
were taken into account when considering this application.
ERMA New Zealand Decision: Application HSC06001
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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) 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
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.
Purpose of the Application
4.3
The purpose of the application is to manufacture in containment Tnl 1146 to conduct
field trials to evaluate whether the substance is suitable for use in New Zealand
agriculture and horticulture and to provide data for a future application for approval for
release.
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
HSNO Act.
Life Cycle
4.5
Taranaki NuChem Limited plans to manufacture up to 20 L of Tnl 1146. The substance
will be stored by Taranaki NuChem Ltd and then transported to the trial site in 1 L
HDPE jerry cans with tamper evident lids, stored in a lockable molded plastic storage
chest. The samples will be prepared and applied at the trial site. Up to 5 trial sites will
be used, and the sites will be more than 100 m from public areas. Disposal procedures
for surplus sample, spray mixtures and used containers are detailed in the Management
Plan supplied by the applicant.
Hazardous Properties
4.6
I note that a containment application requires only sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls.
4.7
The applicant has examined the properties of the components, and considers that the
substance will trigger thresholds for skin irritancy, eye corrosivity, skin sensitisation,
reproductive/developmental toxicity, target organ systemic toxicity, and aquatic
ecotoxicity.
4.8
I have reviewed the applicant’s hazard information and I consider that the information
is sufficient for me to determine that any risks can be managed by the containment
controls.
ERMA New Zealand Decision: Application HSC06001
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Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.9
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.
4.10
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of risk management. I have reviewed the applicant’s
assessment of the risks and agree that it is suitable for the consideration below.
Risks to the Environment
4.11
If released off target, the substance has the potential to cause adverse effects to the
aquatic environment.
4.12
On the basis of the lifecycle of the substance outlined in paragraph 4.5, adverse effects
could arise from:
 an accident during storage, use or transportation, resulting in release of the substance
 failure to follow correct disposal procedures as outlined in the Management Plan
 failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance.
4.13
I consider that, taking into account the properties of the substance, the quantity
involved, the containment regime proposed by the applicant, the containment controls
in Appendix 1 and controls in place under other legislation, there are no significant
risks to the environment. I consider that the controls in place are not too onerous to be
complied with and therefore the risks to the environment are negligible.
Risks to Human Health and Welfare
4.14
If the substance is splashed onto skin or eyes, or ingested there is the potential to cause
adverse effects on human health.
4.15
On the basis of the lifecycle of the substance outlined in paragraph 4.5, adverse effects
could arise from:
 an accident during storage, use or transportation, resulting in release of the substance
 failure to follow correct disposal procedures as outlined in the Management Plan
 failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance.
4.16
I consider that, taking into account the properties of the substance, the quantity
involved, the containment regime proposed by the applicant, the containment controls
in Appendix 1 and controls in place under other legislation, there are no significant
risks to human health and welfare. I consider that the controls in place are not too
onerous to be complied with and therefore the risks to human health and welfare are
negligible.
ERMA New Zealand Decision: Application HSC06001
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Māori issues and concerns
4.17
I have considered the potential Māori cultural effects of this application in accordance
with the Methodology clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO
Act, and the assessment framework contained in the ERMA New Zealand User Guide
“Working with Māori under the HSNO Act 1996”.
4.18
I note that the substance has hazardous properties that trigger HSNO toxicity and
ecotoxicity thresholds. There is the potential for this substance to have a negative
impact on Māori and the mauri of iwi, cultural tāonga and the environment.
4.19
I am unaware of any impacts that the substance could have on Māori culture, or, on
traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and
fauna or other taonga. I have no evidence to suggest that the controlled containmenttrial use of the substance will breach the principles of the Treaty of Waitangi and see no
requirement for the applicant to consult with Māori regarding this application.
4.20
This assessment is made on the condition that the substance is handled, blended, 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
suggested that the appropriate authorities be notified 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
I have evaluated the adequacy of the containment arrangements proposed by 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 HSNO Act, being
 To limit the likelihood of escape of any contained hazardous substance or
contamination by hazardous substances (for example, control 10)
 To exclude organisms from a facility (for example, control 7)
 To exclude unauthorized people from the facility (for example, control 6)
 To prevent unintended release of the substance by experimenters working with the
substance (for example, control 9)
 To control the effects of any accidental release of the substance (for example,
control 19)
 Inspection and monitoring requirements (for example, control 24)
 Qualifications required of the person responsible for implementing the controls (for
example, control 13).
5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, Tnl 1146 can be adequately contained.
ERMA New Zealand Decision: Application HSC06001
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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 Tnl 1146, I am satisfied that
the controls imposed, including those in place under other legislation, will result in the
substance being adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology, I record that, in reaching this
conclusion, I have applied the criteria specified in section 32 of the HSNO Act.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 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.
6.5
The application to import into containment the hazardous substance Tnl 1146 is thus
approved pursuant to section 32 of the HSNO Act, with controls as set out in Appendix
1.
Rob Forlong
Date 17 February 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Tnl 1146: HSC000228
ERMA New Zealand Decision: Application HSC06001
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Appendix 1: List of controls that apply to the
hazardous substance Tnl 1146
1. The trials shall be undertaken in accordance with the Management Plan which
accompanied the application. Modifications of the Management Plan may be approved in
writing by ERMA New Zealand providing that they comply with the following controls.
2. Notwithstanding the requirements of control 1 above, the trials shall also comply with the
following controls:
3. The trials may be carried out at a location that is not defined until an infestation of the
target pest has been found, only if the applicant;
- has permission from the owner of the land to carry out the trial; and
- notifies ERMA New Zealand of the location as per control 22.
4. The trial sites shall be chosen so as to prevent the substance entering any surface water or
groundwater system.
5. The trial sites shall be located to prevent any building where people live or work being
exposed to the substance.
6. 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 allowed, that the site is subject
to a trial, and that the crops should not be removed or disturbed.
7. In any location where it is possible for grazing animals to access the trial site, the trial
sites shall be secured by stock proof fencing to exclude grazing animals for the duration
of the trial.
8. The substance shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS8409: 2004.
9. The substance shall be mixed, diluted and prepared in any other way prior to application
in accordance with the relevant sections of the Code of Practice for the Management of
Agrichemicals NZS8409: 2004.
10. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in accordance
with the Hazardous Substances (Identification) Regulations 2001. A Safety Data Sheet
shall accompany each shipment.
11. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005.
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 Management Plan and approval controls.
ERMA New Zealand Decision: Application HSC06001
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12. The substance 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 the Code of Practice for the Management of
Agrichemicals NZS8409: 2004. 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 of the trial site.
13. The personnel applying the substance to the crops shall be able to demonstrate that they
have the qualifications necessary to carry out the trial. Ways of demonstrating this
include the holding of an appropriate Growsafe certification or an Approved Handler
qualification. They should also be aware of the Management Plan and the controls in
place in order to adequately manage the substance.
14. Any sprayed produce intended for human or animal consumption, or offered for sale shall
comply with the application rate, withholding period and maximum residue levels as set
by the New Zealand Food Safety Authority (NZFSA). Produce not covered under the
NZFSA approval is not to be used for consumption, or offered for sale.
15. Sprayed produce that is not fit for consumption or offered for sale 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 sprayed over a
marked and designated area of the trial site crop, or over an alternative approved crop at
the trial site, or another approved trial site.
17. Any 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 at the site.
18. Surplus substance remaining at the end of the trials shall be returned to Taranaki NuChem
Ltd for secure storage in an exempt laboratory, exported or degraded to non-hazardous
substances (note that once the trials are complete the substance does not have approval to
be present in New Zealand except in an exempt laboratory).
19. Any accidental spillage of the unmixed substance or spray mix shall be contained and
prevented from entering waterways. Spillage shall either be diluted with water or earth
and spread over, or buried in a waste area, or taken to an approved landfill.
20. A record shall be kept of all use of the substance. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Classes 6, 8 and 9 Controls)
Regulations 2001.
21. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s toxic and ecotoxic properties shall accompany the substance at all stages of
its lifecycle. Personal protective equipment, including eye protection, shall be worn
when handling the substance during the use stage of the lifecycle.
ERMA New Zealand Decision: Application HSC06001
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22. 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
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
Tnl 1146
HSC06001
HSC000228
Emma Doust
23. 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
waterway, the relevant iwi authorities be advised.
24. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
25. This approval remains in place for the term of any concurrent approval required under the
Agricultural Compounds and Veterinary Medicines Act 1997, to a maximum of five
years.
26. The maximum total quantity of Tnl 1146 that shall be manufactured under this approval
is 20 Litres.
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