ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
24 November 2004
Application Code
HSC04032
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
BASF New Zealand
PO Box 20 389
Bishopdale
Christchurch 8005
To field test the substance BNZ0204 to assess the
efficacy and phytotoxicity
Applicant
Purpose of the Application
Date Application Received
14 October 2004
Consideration Date
24 November 2004
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substance BNZ0204 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.
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
BNZ0204
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.
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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 14 October 2004 and assessed as having
sufficient information on 18 October 2004.
3.2
Project Team:
Beth Dye
Programme Manager, Applications (Hazardous
Substances)
Sue Scobie
Senior Adviser (Hazardous Substances)
Linda Robinson
Manager, Māori Unit
Report review and sign-out by:
Noel McCardle
Senior Applications Adviser, Hazardous
Substances
3.3
The applicant supplied the following documents:
 The application, including confidential appendices.
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)).
3.5
Responses were received from
 The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines 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.’
 The Ministry of Health stating; ‘with appropriate 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 (nonoccupational).’
3.6
The applicant was provided with a copy of the proposed controls for BNZ0204 and
given the opportunity to comment on them. The applicant replied that they had no
comments to make on the proposed controls.
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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 field test the substance BNZ0204 to assess the
efficacy and phytotoxicity.
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.
Life Cycle
4.5
The applicant has provided the following details of the lifecycle.
4.6
Three litres of the substance will be imported in each of 2004 – 2007. It will arrive
packed in 0.25 or 0.5 litre containers which are suitable for transport to researchers, and
will be stored by BASF New Zealand Ltd.
4.7
The substance will be distributed to researchers, who will dispense it into spray mix
quantities, and transport them to the site, where the spray mixture will be prepared and
applied. Disposal procedures for surplus sample, spray mixture and used containers are
detailed in the Management Plan supplied by the applicant.
Hazardous Properties
4.8
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.
4.9
The applicant states that there is limited data available on the substance, as it is still
under development. The applicant has examined the properties of the components, and
considers that the substance will trigger thresholds for aquatic ecotoxicity and terrestrial
invertebrate ecotoxicity.
4.10
Consideration of information on components on ERMA New Zealand databases
indicates that BNZ0204 may also trigger thresholds for skin irritancy, contact
sensitisation, and target organ systemic toxicity. I have taken this into account in my
review of the substance’s hazardous properties, and consider that the information is
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sufficient for me to determine that any risks can be managed by the containment
controls.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
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.
4.12
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
4.13
If released into waterways, the substance has the potential to cause adverse effects on
aquatic organisms. If released into the environment, the substance has the potential to
cause adverse effects on terrestrial invertebrates.
4.14
On the basis of the lifecycle of the substances outlined in paragraph 4.5 – 4.7, 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.
4.15
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.
Risks to Human Health and Welfare
4.16
The applicant considers that the substance will not trigger any toxic thresholds. I note
that BNZ0204 is still under development and therefore data is still incomplete. I
consider that it is possible that the substance may have adverse effects on human health
and welfare if it is ingested or contacts eyes or skin.
4.17
On the basis of the lifecycle of the substances outlined in paragraph 4.5 – 4.7, 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.
4.18
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.
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Māori issues and concerns
4.19
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”.
4.20
On the basis of the information provided by the ERMA New Zealand Manager (Māori),
I consider that the substance is 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. This is on the condition that the substance is
used in accordance with the controls in Appendix 1, and in accordance with any other
relevant controls applied under other legislation.
4.21
In addition, the trial of this substance does not involve significant community exposure
or significant exposure to the environment, so I consider that there is no requirement for
the applicant to consult with Māori regarding this application.
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 Act, being
 To limit the likelihood of escape of any contained hazardous substances 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 substances 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, BNZ0204 can be adequately contained.
6
Decision
6.1
I have considered this application under section 31 to import into containment
hazardous substances, and pursuant to section 32, I am satisfied that this application is
for the purpose specified in section 30(ba).
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6.2
Having considered the risks associated with the lifecycle of BNZ0204, 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 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 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 BNZ0204 is thus
approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date 24 November 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
BNZ0204:
HSC000133
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Appendix 1: List of controls that apply to the
hazardous substance BNZ0204
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.
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.
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11. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 1999.
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 would
include the holding of an appropriate Growsafe certification or an Approved Handler
qualification.
14. No sprayed produce shall be consumed by people or animals or offered for sale.
15. Sprayed produce 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 at the 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 BASF New
Zealand Ltd for secure storage in an exempt laboratory, exported or degraded to nonhazardous substances (note that once the trials are complete the substances do 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,
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.
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 shall be worn when handling the substance
throughout the lifecycle.
22. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing (by letter, fax
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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
BNZ0204
HSC04028
HSC000133
Beth Dye
23. 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. 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 the substance that shall be imported or manufactured
under this approval is twelve litres.
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