ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
1 September 2004
Application Code
HSC04016
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
BASF New Zealand Limited
Purpose of the Application
To import for field testing various substances to assess
their ability to control damaging organisms in plants
Date Application Received
16 July 2004
Consideration Date
27 August 2004
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the group of hazardous substances BNZ01/04 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 group of substances has been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
BNZ-01/04
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
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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 July 2004.
3.2
Project Team:
Beth Dye
Acting Programme Manager, Applications
(Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Robinson
Manager, Māori
Report review and sign-out by:
Peter Dawson
Principal Scientist (Hazardous Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices, including limited substance information, a Site
Management Plan and Project Plans.
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
A response was received from
 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) given that the substances are limited for experimental purposes only.’
3.6
The applicant has advised that the ACVM Group has determined that as the substances
described in this application are not trade named products and any treated food crop is
destroyed, these substances do not require approval under the Agricultural Compounds
and Veterinary medicines Act 1997.
3.7
The applicant was provided with a copy of the proposed controls for BNZ-01/04 and
given the opportunity to comment on them. The comments received were taken into
consideration when the controls were finalised.
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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 application code of BNZ-01/04 covers a small amount (maximum 0.5 litre/year) of
each of a number of novel chemicals formulated as emulsifiable concentrates, aqueous
concentrates or suspension concentrates. The purpose of the application is to import
them for field testing to assess their ability to control damaging organisms in plants.
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.
Hazardous 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.
4.6
The applicant states that as these substances are still in the early exploratory phase of
their development, only very limited data are available. General knowledge of the
chemical groups involved indicates that the substances will not trigger explosive,
oxidising or corrosive thresholds. Some of the substances will trigger a flammable
threshold as a result of the inclusion of cyclohexanone in the formulation. In the
absence of any data, the applicant has assumed the worst case and triggered all Class 6
and Class 9 thresholds, noting that it is unlikely that any one of the substances will
trigger all the thresholds.
4.7
I have reviewed the applicant’s hazard information. This is insufficient to fully
describe the hazards of the substances but provides a workable basis for setting the
containment controls to ensure that any risks can be adequately managed.
Life Cycle
4.8
BASF New Zealand Ltd plans to import a maximum of 0.5 litre of each of a number of
substances of various chemical groups. (BASF also notes that in reality many
substances may only be imported in volumes of 25-50 mL / year). The substances will
be air freighted into Christchurch, and taken by road to a purpose designed secure
facility at BASF until required for application. The substances will be dispensed at the
trial sites (identified in the Project Plans) into spray equipment already containing
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appropriate volumes of water for dilution to provide a spray mixture that is used within
an hour of being prepared. The applicant states that there will be no surplus spray to be
disposed of. At completion of the final spray, spray bottles will be triple rinsed,
washings disposed of at the trial site (Control 17) and spray bottles will be disposed of
at the local landfill. Any substances unused at the end of the season will be retained as
backup for the following season or returned to the originating laboratory overseas. The
applicant states that there will be no local disposal of unused substances.
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
As these substances are still in the early exploratory phase of their development, only
very limited data are available. If released into the environment, the substances may
result in adverse effects.
4.12
On the basis of the lifecycle of the substances outlined in paragraph 4.8, adverse effects
could arise from:
 An accident during storage, use or transportation, resulting in release of the
substances
 Incorrect use resulting in spray drift
 Failure to follow correct disposal procedures as outlined in the Management Plan.
4.13
I consider that, taking into account 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.
Risks to Human Health and Welfare
4.14
As these substances are still in the early exploratory phase of their development, only
very limited data are available. If released, the substances may result in adverse effects
to human health and welfare.
4.15
On the basis of the lifecycle of the substances outlined in paragraph 4.8, adverse effects
could arise from:
 An accident during storage, use or transportation, resulting in release of the
substances
 Incorrect use resulting in spray drift
 Failure to follow correct disposal procedures as outlined in the Management Plan.
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4.16
I consider that as a precautionary measure, safety glasses, gloves and protective
clothing shall be worn when handling the substance throughout the lifecycle (control
21).
4.17
I consider that, taking into account 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.
Māori issues and concerns
4.18
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”.
4.19
On the basis of the information provided by the ERMA New Zealand Manager (Māori),
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. 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 applied under other legislation.
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
 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
substance
 To control the effects of any accidental release of the substance
 Inspection and monitoring requirements
 Qualifications required of the person responsible for implementing the controls
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, BNZ-01/04 can be adequately contained.
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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).
6.2
Having considered the risks associated with the lifecycle of BNZ-01/04, 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:
 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 substances BNZ-01/04 is thus
approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date 1 September 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
BNZ-01/04:
HSC000102
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Appendix 1: List of controls that apply to the
hazardous substances BNZ-01/04
1. The trials shall be undertaken in accordance with the Project Plans and Site Management
Plan, which accompanied the application. Modifications of the Project Plan or Site
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 trial sites shall only be located on the three properties identified in the Project Plans.
4. The trial sites shall be chosen so as to prevent the substances 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 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.
7. The trial sites shall be secured by stock proof fencing to exclude grazing animals for the
duration of the trial.
8. The substances shall be stored in accordance with good practice. This would generally
be achieved through compliance with the Code of Practice for the Management of
Agrichemicals NZS8409.
9. The substances shall be mixed, diluted and prepared in any other way prior to application
in accordance with good practice. This would generally be achieved through compliance
with the Code of Practice for the Management of Agrichemicals NZS8409.
10. The substances shall be securely packed in suitable containers as appropriate that comply
with the Hazardous Substances (Packaging) Regulations 2001, and shall be labelled as
appropriate in accordance with the Hazardous Substances (Identification) Regulations
2001. Appropriate MSDS shall accompany each shipment.
11. The substances shall be transported in accordance with good practice. This may require
compliance with the Land Transport Rule: Dangerous Goods 1999.
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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12. 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. 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 substances 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 (including spray bottles) 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 substances remaining at the end of each season shall be returned to BASF New
Zealand Ltd for secure storage in a purpose designed secure facility. At completion of
the programme, empty substance bottles and any unused substances shall be exported to
the originating laboratory.
19. Any accidental spillage of 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.
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. Information on appropriate safety precautions necessary to provide safeguards against the
substances’ ecotoxic and toxic properties shall accompany the substances at all stages of
their lifecycle. Safety glasses, gloves and protective clothing shall be worn when
handling the substance for the purposes of dispensing, mixing or applying the substance,
or when cleanup is required.
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
BNZ-01/04
HSC04016
HSC000102
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, both the relevant
regional council and the relevant iwi authorities be advised.
24. The Authority or its authorised agent or properly authorised enforcement officers, may
whilst accompanied by the Study Director or the Trial Director inspect the facilities and
trial sites at any reasonable time.
25. This approval remains in place for a maximum of five years.
26. The maximum quantity of BNZ-01/04 that shall be imported under this approval is 0.5
litre of each substance per year.
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