ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
13 July 2005
Application Code
HSC05012
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 BCS002-05 to assess its
efficacy under New Zealand conditions
Date Application Received
9 June 2005
Consideration Date
12 July 2005
Considered by
Dr Donald Hannah, Acting Chief Executive of ERMA
New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substance BCS002-05 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:
BCS002-05
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 9 June 2005.
3.2
Project Team:
Emma Doust
Applications Adviser (Hazardous Substances)
Sue Scobie
Senior Science Adviser (Hazardous Substances)
Zack Bishara
Acting Maori Manager
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.
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
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.’
 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 (nonoccupational).’
3.6
The applicant was provided with a copy of the proposed controls for BCS002-05 and
given the opportunity to comment on them. No comments were received.
ERMA New Zealand Decision: Application HSC05012
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4
Consideration
Sequence of the Consideration
4.1
This application was considered by the Acting 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 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 BCS002-05 to assess its
efficacy 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 6 L of BCS002-05. One to two litres will
be imported initially, and then further quantities will be imported if trial work
demonstrates that further work is warranted.
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 BCS002-05
is an acute toxicant to humans (via ingestion) and an aquatic ecotoxicant. On the basis
of the data supplied, the Agency considers that the substance does not trigger the
threshold for acute toxicity.
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.
ERMA New Zealand Decision: Application HSC05012
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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:
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.
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.
Risks to Human Health and Welfare
4.15
On the basis of the data supplied the Agency considers that there are no human health
hazards associated with this substance; and as such consider that this matter need not be
considered further.
Māori issues and concerns
4.16
I have considered the potential Māori cultural effects in accordance with clauses 9(b)(i)
and 9(c)(iv) of the Methodology 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.
4.17
I agree with the applicant that consultation was not required for this application due to
the negligible potential risks associated with its importation into containment./
4.18
I consider that these negligible potential risks will be further minimised due to the
proposed field trial purpose, nature of the substances use, and proposed controls.
4.19
From the information provided, I consider that the application is unlikely to have an
impact on the relationship between Māori culture and their 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 HSNO controls
established for this application, and in accordance with any other relevant controls
applying under other legislation.
ERMA New Zealand Decision: Application HSC05012
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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
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To limit the likelihood of escape of any contained hazardous substances or contamination by
hazardous substances (for example, controls 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, BCS002-05 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).
6.2
Having considered the risks associated with the lifecycle of BCS002-05, 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:
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6.5
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.
The application to import into containment the hazardous substance BCS002-05 is thus
approved pursuant to section 32 of the HSNO Act, with controls as set out in Appendix
1.
Dr Donald Hannah
Date 13 July 2005
Acting Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC05012
BCS002-05:
HSC000158
Page 5 of 8
Appendix 1: List of controls that apply to the
hazardous substance BCS002-05
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.
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 HSC05012
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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 NZS8409:2004.
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.
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.
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:
ERMA New Zealand Decision: Application HSC05012
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Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
BCS002-05
HSC05012
HSC00158
Emma Doust
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 BCS002-05 that shall be imported under this approval is 6 L.
ERMA New Zealand Decision: Application HSC05012
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