ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
23 September 2005
Application Code
HSC05032
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
BCS006-05 To import into containment and field test
the substance BCS006-05 to assess the efficacy and
phytotoxicity under New Zealand conditions (Field
Trial).
Date Application Received
23 August 2005
Consideration Date
23 September 2005
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substance BCS006-05 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:
BCS006-05
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 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 23 August 2005.
3.2
Project Team:
Emma Doust
Applications Adviser (Hazardous Substances)
Chris Geering
Science Adviser (Hazardous Substances)
Peter Jackson
Advisor, Maori Unit
Report review and sign-out by:
Beth Dye
Applications Manager (Hazardous Substances)
3.3
The applicant supplied the following documents:
 The application
 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 (Workplace Group)
 The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
Response were 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 administrated 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 BCS006-05 and
given the opportunity to comment on them. No comments were received.
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 HSNO 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 HSNO Act.
Purpose of the Application
4.3
The purpose of the application is to field test the substance BCS006-05 to assess its
efficacy and phytotoxicity under New Zealand conditions.
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
Bayer New Zealand Ltd plans to import up to 20 L of BCS006-05. Five litres will be
imported initially, and then further quantities will be imported if trial work is
promising.
4.6
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.
4.7
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.
Hazardous Properties
4.8
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.
4.9
The applicant has assessed the available information and has identified that BCS006-05
is an acute oral and dermal toxicant and an aquatic ecotoxicant.
4.10
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.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
The applicant has identified and assessed potential risks and detailed proposals for, and
impacts of, risk management. I have reviewed the applicant’s assessment of the risks to
the environment, human health and welfare and Maori issues and concerns as set out
below:
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Risks to the Environment
4.12
If released off target, the substance has the potential to result in adverse effects on
aquatic organisms.
4.13
On the basis of the lifecycle of the substance outlined in paragraphs 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
 Failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance.
4.14
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
4.15
If the substance is ingested or comes in contact with skin there is the potential to cause
adverse effects on human health.
4.16
On the basis of the lifecycle of the substance 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
 Failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance.
4.17
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.
Māori issues and concerns
4.18
I have considered the potential Māori cultural effects in accordance with the
Methodology clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO Act. In
addition, I have used the assessment framework contained in the ERMA New Zealand
User Guide “Working with Māori under the HSNO Act 1996” in assessing this
application.
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4.19
I have noted that BCS006-05 has hazardous properties that trigger several HSNO
toxicity and ecotoxicity thresholds. There is the potential that this substance could have
a negative impact on Māori and the mauri of iwi, cultural tāonga and the environment.
4.20
After careful consideration of the risks associated with this substance (paragraphs 4.124.17 above), I am unaware of any likely impact BCS006-05 could have on Māori
culture or traditional relationships with ancestral lands, water, sites, wāhi tapu, valued
flora and fauna or other taonga. I have no evidence to suggest that the use of BCS00605 in containment will breach the principles of the Treaty of Waitangi and see no
requirement for the applicant to consult with Māori regarding this application.
4.21
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 Trial Director notify the appropriate authorities 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 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 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, BCS006-05 can be adequately contained.
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).
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6.2
Having considered the risks associated with the lifecycle of BCS006-05, 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 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 BCS006-05 is thus
approved pursuant to section 32 of the HSNO Act, with controls as set out in Appendix
1.
Rob Forlong
Date 23 September 2005
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
BCS006-05:
HSC000221
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Appendix 1: List of controls that apply to the
hazardous substance BCS006-05
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 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 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 NZS8409:2004.
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 NZS8409:2004.
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 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 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
NZS8409:2004. 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 controls in place in
order to adequately manage the substance.
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 triple rinsed after use with an 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 in original containers for secure storage in an exempt laboratory, or disposed
of via an external commercial incineration company, (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 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. Safety glasses, gloves and protective clothing shall be worn when handling
the substance throughout the lifecycle.
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22. The Department of Labour [Attn. HSNO Project Manager (Workplace Group) P O Box
3705, Wellington] 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
BCS006-05
HSC05032
HSC000221
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 BCS006-05 that shall be imported under this approval is
20L.
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