ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
29 June 2004
Application Code
HSC04007
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
Bayer New Zealand Limited
Purpose of the Application
To field test the substance BCS004-04 to assess the
efficacy and phytotoxicity
Date Application Received
26 May 2004
Consideration Date
29 June 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 BCS004-04 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 substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
BCS004-04
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 26 May 2004 and assessed as having
sufficient information on the same day.
3.2
Project Team:
Claire O’Hehir
Applications Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Robinson
Manager, Māori
Report review and sign-out by:
Beth Dye
Acting Programme Manager, Applications
(Hazardous Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices, containing limited compositional information, a Safety
Data Sheet for a similar substance, a Management Plan and a Project Plan.
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 New Zealand Food Safety Authority (Agricultural
Compounds and Veterinary Medicines Group (ACVM Group)) stating that; ‘any issues
which may arise under the Acts administration 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 BCS004-04 and
given the opportunity to comment on them. The comments received were taken into
consideration when the controls were finalised.
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).
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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 BCS004-04 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.
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 has assessed the available information and has identified that the
hazardous properties of BCS004-04 are limited to toxic (acute oral toxicity and skin
irritancy) and ecotoxic (aquatic and terrestrial vertebrate) properties.
4.7
I have reviewed the applicant’s hazard information and consider that it is sufficient to
describe the hazards associated with the substance to ensure that any risks can be
managed by the containment controls.
Life Cycle
4.8
Bayer New Zealand Ltd plans to import up to 1 kg of BCS004-04. It will be stored by
Bayer New Zealand Ltd and will be dispensed into spray mix quantities prior to
transporting to the trial site, where the spray mixture will be prepared and applied.
Appropriate disposal procedures for surplus sample, spray mixture and used containers
and appropriate post-treatment management of the trial site are detailed in the
Management Plan supplied by the applicant.
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.
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Risks to the Environment
4.11
If released into waterways, the substance has the potential to result in adverse effects on
aquatic organisms. If the substance does not remain contained, it may have adverse
effects on terrestrial vertebrates.
4.12
On the basis of the lifecycle of the substance outlined in paragraph 4.8, 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.
4.13
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.
Risks to Human Health and Welfare
4.14
Ingestion of the substance or contact of the substance with skin may result in adverse
effects on human health and welfare.
4.15
On the basis of the lifecycle of the substance outlined in paragraph 4.8, adverse effects
on human health and welfare could arise from:
 An accident, resulting in exposure during storage, use or transportation
 Failure to follow safety precautions for spray preparation and use as detailed in the
Management Plan
 Failure to follow correct disposal procedures as outlined in the Management Plan.
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.
Māori issues and concerns
4.17
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”.
4.18
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.
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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, BCS004-04 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 BCS004-04, 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 BCS004-04 is thus
approved pursuant to section 32 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:
BCS004-04:
HSC000089
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Appendix 1: List of controls that apply to the
hazardous substance BCS004-04
1. The trials shall be undertaken in accordance with the Project Plan and Management Plan,
which accompanied the application. Modifications of the Project Plan or 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, provided the applicant;
- has permission from the owner of the land to carry out the trial; and
- notifies ERMA New Zealand of the locations 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 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 substance 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 substance 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 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 MSDS 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 accordance with good practice. This may require
compliance with 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 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 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 Bayer New
Zealand Ltd for secure storage in an exempt laboratory, exported or degraded to a nonhazardous substance (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,
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 (Class 6, 8 and 9 Controls)
Regulations.
21. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s ecotoxic and toxic properties shall accompany the substance at all stages of
its lifecycle. This shall include information on the appropriate protective clothing that is
to be used and relevant first aid measures for immediate action pending medical attention.
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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
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
BCS004-04
HSC04007
HSC000089
Claire O’Hehir
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 BCS004-04 that shall be imported under this approval is
1 kg.
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