Amended under s67A on 10 January 2008
January 2007
Application Code HSC06011
Application Type
Applicant
To import or manufacture hazardous substances in containment under Section 31 of the Hazardous Substances and New Organisms Act 1996 (the Act).
HortResearch
Te Puke
New Zealand
Purpose of the Application
Date Application Received
Consideration Date
HR-BCA-N/ HR-BCA-N2: to manufacture and test in containment the efficacy of prototype biopesticides against armoured scale insects in kiwifruit crops (field trial)
12 July 2006
12 January 2007
Considered by Rob Forlong, Chief Executive of ERMA New Zealand
1.1
The application to manufacture and trial in containment the hazardous substances,
HR-BCA-N and HR-BCA-N2 is approved with controls in accordance with the relevant provisions of the Act and the Hazardous Substances and New Organisms (Methodology)
Order 1998 (the Methodology).
1.2
HR-BCA-N
HR-BCA-N2
2.1
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
The application was lodged pursuant to section 31. The decision was determined in accordance with section 32, taking into account additional matters to be considered in that section and matters specified under Part II of the Act and the provisions of Part

III of the Third Schedule of the Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the 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.
3.1
3.2
The application was formally received on 12 July 2006.
On 2 August 2006 the applicant was requested under section 58 to provide further information on the application.
3.3
A revised application form was lodged on 14 December 2006.
3.4
Project Team:
Brendon Noonan
Sue Scobie
Linda Robinson
Advisor (Hazardous Substances)
Senior Advisor (Hazardous Substances)
General Manager (Māori Unit)
Report review and sign-out by:
Beth Dye Applications Manager (Hazardous Substances)
3.5
The applicant supplied the following documents:
 the application
 confidential appendices including details on the formulation and taxonomic identification of the biocidal component and MSDSs for other components in the substances.
3.6
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); and
 The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
3.7
A response was received from the ACVM 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”.
3.8
The applicant was provided with a copy of the proposed controls for HR-BCA-N and
HR-BCA-N2 and was given the opportunity to comment on them. The comments received from the applicant were taken into account when considering this application.
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4.1
This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e)).
4.2
In accordance with section 32, 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 substances could be adequately contained by controls to provide for each of the matters specified in Part III of the Third Schedule of the Act.
4.3
The purpose of the application is to manufacture and field trial in containment the efficacy of a range of prototype biopesticides for the control of armoured scale insects on kiwifruit.
4.4
The Agency considers that the purpose of the application, as specified, amounts to
“research and development” and as such considers that the application qualifies for consideration under section 30(ba).
4.5
Manufacture
The active insecticidal ingredient (a fungus) will be cultured in HortResearch’s Natural
Products and Ecological Production Building at the Ruakura Research Centre,
Hamilton. Aqueous HR-BCA-N solutions will also be formulated at this facility.
Granular HR-BCA-N2 formulations will be manufactured within laboratories in the
BioEngineering Technologies building at the Ruakura Research Centre. The applicant has stated that the granulation process is novel and has provided details of the process on a confidential basis.
4.6
Transportation
For manufacture of the granular HR-BCA-N2 formulations the fungal material will be transported from the culturing facility to the Bioengineering laboratory in air tight containers.
4.7
Both the aqueous and granular formulations will be carried in air tight containers from their respective laboratories to HortResearch’s Te Puke Research Centre in company vehicles.
4.8
Storage
The HR-BCA-N and HR-BCA-N2 formulations will be stored at the Te Puke
Research Centre in a dedicated pathology laboratory.
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4.9
Field trialling
Nominated HortResearch staff will set up and carry out the field trials at the Te Puke
Research Facility. Trial set up will include the selection of kiwifruit vines to be included in the trials. The vines will be marked off using barrier tape and signs will also be erected stating that the no unauthorised access is permitted and that fruit or organic matter should not be removed from the area or be consumed.
4.10
The granular HR-BCA-N2 formulations will be mixed in water prior to application and either type of formulation (aqueous or the water dispersible granules) will be spot applied to kiwifruit using a brush. Three to four weeks after application all treated insects, and fruit on which they reside will be removed from the kiwifruit vines and be retained for further analysis within the laboratory. This further analysis will be carried out within the Te Puke Pathology laboratory. The applicant has stated that the trials will run over an eight week period.
4.11
The applicant intends to replicate the trials the following season (2007/2008) using the same active ingredient but may modify the formulations and the size and frequency of experimentation. It is noted that, if the modified formulations are not covered by the formulation descriptions of HR-BCA-N and HR-BCA-N2 as disclosed in this application, a new application may be required.
Disposal
4.12
The applicant has stated that all biological material and equipment that comes into contact with the active ingredient during the manufacture and trialling of HR-BCA-N and HR-BCA-N2 will either be bagged and placed in biohazard bins for disposal or be autoclaved (120 o C, 80 kpa, 15 min) and then washed before disposal or reuse.
4.13
Treated fruit and other organic material removed from the study vines will be buried or mulched in with other experimental fruit within the Te Puke Research Centre’s orchard.
Containment provisions
4.14
The applicant has stated that both the facilities used at the Te Puke and Ruakura
Research Centres are access restricted. Access to both sites is limited to staff and seasonal contractors with visitors having restricted access only. Both facilities are gated at night and have evening security patrols.
4.15
Containment applications typically only require a sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls.
4.16
The applicant’s hazard information has been reviewed by the Agency and although it contains only limited information on the potential hazards posed by the substances it is considered impractical for the applicant to provide more information on the substances’ hazards given the nature of the trial i.e. proof of concept. Given the small
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quantities of the substances involved and the adoption of precautionary measures described in the application the Agency considers that any risks can be managed by the containment controls.
4.17
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the potential risks of escape from containment were considered under the headings of environmental, human health and welfare and Māori issues and concerns.
4.18
Within the application the applicant has claimed that the manufacture and trialling of
HR-BCA-N and HR-BCA-N2 should only pose a minimal risk to public health or the environment. However, the applicant has also stated that the actual risks posed by the substances are unknown at this stage and has detailed proposals for risk management.
Evaluation of risks to the environment
4.19
Because the hazards of the substances are not clearly defined or understood it is considered that the substances have the potential to cause adverse effects within any part of the environment. For example, the substances may adversely affect the vines bearing treated fruit. Alternatively the substances may be spilt and have adverse effects within the soil or aquatic environments or allow for the exposure of terrestrial vertebrates or invertebrates.
4.20
On the basis of the substances’ lifecycles, as outlined in paragraphs 4.5 to 4.14, adverse effects could arise from:
 an incident during manufacture, transportation or use resulting in release of the substances.
 failure to follow correct disposal procedures as outlined in the application and
Appendix 1.
 failure to follow the correct operational procedures as set out in the controls, resulting in release of the substances.
4.21
Taking into account the quantities of the substances involved, the containment/study regimes proposed by the applicant, the containment controls proposed in Appendix 1 and controls imposed under other legislation the Agency considers that no significant risks will be posed to the environment from the contained manufacture and trialling of
HR-BCA-N and HR-BCA-N2.
Evaluation of risks to human health and welfare
4.22
In assessing the risks to human health, the Agency considers it unlikely that persons will experience chronic effects as a result of the contained trials because of the short duration and non-repetitive nature of the trials. The Agency considers that acute effects pose the greatest risk to human health. For example the substances may be splashed onto skin or eyes or accidentally ingested either directly or through the consumption of treated fruit.
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4.23
On the basis of the substances’ lifecycles, as outlined in paragraphs 4.5 to 4.14 adverse effects could arise from:
 an incident during manufacture, packaging, storage, transportation or use, resulting in release of the substance.
 failure to follow correct disposal procedures as outlined in the application and
Appendix 1.
 failure to follow the correct operational procedures as set out in the controls resulting in release of the substances from containment.
4.24
In considering the risks posed to human health through the manufacture and trialling of these substances, the Agency has noted the uncertainties around the substances’ hazardous natures. However, given the small quantities of the substances involved, their limited accessibility, the containment/trial regime described in the application, the containment controls proposed in Appendix 1 and controls posed under other legislation, the Agency considers that the risks posed to human health and welfare through the manufacture and trialling of HR-BCA-N and HR-BCA-N2 in containment will be limited.
Māori issues and concerns
4.25
The Agency has considered the potential Māori cultural effects of this application in accordance with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8, and the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the HSNO Act 1996”.
4.26
It is noted that there is limited information available regarding the substances’ hazards.
However, from the information provided, the Agency considers that there is potential for these substances to have a negative impact on Māori and the mauri of iwi, cultural tāonga and the environment should the substances be released from containment.
4.27
Taking into consideration the containment measures outlined by the applicant,
Kaupapa Kura Taiao considers that any likely impact HR-BCA-N and HR-BCA-N2 may have on Māori culture, or, on traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga is minimal. The Agency has no evidence to suggest that the controlled contained trialling of the substances will breach the principles of the Treaty of Waitangi and sees no requirement for the applicant to consult with Māori regarding this application.
4.28
This assessment is made on the condition that the substances are 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 appropriate authorities be notified 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.
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5.1
The Agency has evaluated the adequacy of the containment arrangement proposed by the applicant and has proposed a suite of controls, as listed in Appendix 1. These controls cover the matters set out in Part III of the Third Schedule of the Act and cover the following aspects:
 To limit the likelihood of escape of any contained hazardous substance or contamination by hazardous substances (for example, control 10)
 To exclude organisms from a facility (for example, control 20)
 To exclude unauthorized people from the facility (for example, control 15)
 To prevent unintended release of the substance by experimenters working with the substance (for example, control 18)
 To control the effects of any accidental release of the substance (for example, control 24)
 Inspection and monitoring requirements (for example, control 31)
 Qualifications required of the person responsible for implementing the controls
(for example, control 16).
5.2
The Agency considers that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, HR-BCA-N and HR-BCA-N2 can be adequately contained.
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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),
“research and development on any hazardous substance”.
6.2
Having considered the risks associated with the lifecycle and uncertainties relating to the hazards of HR-BCA-N and HR-BCA-N2, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substances being adequately contained. I also consider that the controls in place are not too onerous to be complied with.
6.3
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have applied the criteria specified in section 32.
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 substance;
 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 manufacture and conduct field trials in containment of the hazardous substances, HR-BCA-N and HR-BCA-N2, is thus approved pursuant to section 32, with controls as set out in Appendix 1.
Rob Forlong Date 12 January 2007
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
HR-BCA-N: HSC000262
HR-BCA-N2: HSC000263
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Amendment January 2008
An amendment has been made to HR-BCA-N and HR-BCA-NZ to have the words fungicidal based deleted from page 3, section 4.3, second line.
Rob Forlong
Date 10 January 2008
Chief Executive, ERMA New Zealand
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General
1.
All lifecycle stages from manufacture to disposal shall be undertaken in accordance with the information provided by the applicant with their application. Modification of this information may be approved in writing by ERMA New Zealand providing that it complies with the following controls.
2.
Notwithstanding the requirements of control 1, the manufacture and trialling of HR-
BCA-N and HR-BCA-N2 formulations shall also comply with the following controls:
3.
This approval remains in place for five years from the date of this Decision.
Manufacture
4.
HortResearch shall manufacture the substances HR-BCA-N and HR-BCA-N2 in containment within laboratories at their Ruakura Research Centre.
5.
This approval only applies to the manufacture of substances that contain the fungus specified in the application.
6.
7.
The maximum quantity per year of any HR-BCA-N or HR-BCA-N2 formulations that may be manufactured under this approval is 5 L or 2 kg.
Packaging and information
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
8.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001. The label must also set out instructions that any remaining substance must be returned in its original container to HortResearch for storage or sterilisation and subsequent disposal.
9.
A Safety Data Sheet, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each batch and be held at the each trial site during the period of the trial.
Storage
10.
The substances shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004.
Transport
11.
The substances shall be transported in compliance with any relevant requirements of the Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 or the
Maritime Transport Act 1994.
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General handling of the substances
12.
Appropriate personal Protective Equipment (PPE), for example, safety glasses, gloves, respiratory and protective clothing shall be worn when handling the substances during manufacture, use and disposal.
Trial Conditions
13.
Trials may only be conducted within HortResearch’s Te Puke research facility. This includes the orchard and the on site laboratory facilities.
14.
The HR-BCA-N and HR-BCA-N2 formulations shall only be applied to kiwifruit (fruit only) on pre-selected and identified vines.
15.
Access to the trial sites shall be by permission of the Trial Director 1 , or nominated researcher. 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 permitted, that the site is subject to a trial, and that fruit or plant matter should not be removed.
16.
During use the substances shall be under the control of experimental staff, who are experienced in the handling and application of pesticides under test conditions using the specified equipment. Experimental staff shall be made aware of the study protocol and the controls in place in order to adequately manage the substances.
17.
The substances shall be mixed, diluted and prepared prior to application in accordance with the relevant sections of the Code of Practice for the Management of
Agrichemicals NZS 8409: 2004.
18.
The substances shall be applied directly to selected kiwifruit using brush type applicators. When treated fruit are harvested for further laboratory analysis they shall be kept in containment.
19.
Trials shall be conducted in a manner such as to prevent the substances entering surface or ground water systems, the soil environment contaminating kiwifruit vines bearing treated fruit or any other plants.
20.
The trials shall be conducted and managed so as to prevent vertebrates and non- target invertebrates from coming into contact with the substances throughout the trials.
21.
Fruit and vines bearing treated fruit shall be clearly identified as belonging to this trial and statements displayed to the effect that no fruit should be taken for purposes other than for the study or be consumed by persons or animals.
22.
At completion of the trials all contaminated plant matter (treated fruit and contaminated vine) shall be sterilised and be disposed of in a designated area within the research orchard by burying or mulching in.
1 The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the trial in accordance with that proposed in the application and the approval controls.
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23.
A record shall be kept of the use of the substances. This record shall cover all matters referred to in Regulation 6(1) of the Hazardous Substances (Class 6, 8, and 9 Controls)
Regulations 2001 and must be kept for not less than 3 years after the date on which the substance that the record relates to is applied or discharged.
Emergency Management
24.
Any spillage of the substances shall be contained, prevented from entering water bodies, and absorbed with an appropriate absorbent material when appropriate. The absorbent material shall be placed in sealed containers and disposed of appropriately.
All clean up materials shall be treated in a manner to destroy any viable cells within the substance.
Disposal
25.
Any surplus substance remaining at the end of the trials shall be returned to
HortResearch where it will be securely stored in a laboratory complying with the requirements set out in the Hazardous Substances (Exempt Laboratories) Regulations
2001 for the purpose of further analysis or until disposed of.
26.
Any surplus substance shall ultimately be treated in a manner to destroy any viable cells associated with the active ingredient and render the substance, as a whole, nonhazardous. Disposal shall be carried out in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001.
27.
Once the trials are completed the substances will not have approval to be present in
New Zealand except within an exempt laboratory.
28.
Containers no longer used to contain the substances or residue or rinsate from equipment used to handle the substances shall be disposed of in a manner compliant with the Hazardous Substances (Disposal) Regulations 2001. All containers and equipment shall be treated in a manner to destroy any viable cells within the active ingredient prior to their disposal or reuse.
Notification and inspection
29.
The Department of Labour [Attn. HSNO Project Manager (Workplace Group) 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
HR-BCA-N/ HR-BCA-N2
HSC06011
HSC000
Brendon Noonan
30.
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.
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31.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. Trial documentation, as described in Control 1, notwithstanding its confidential nature, shall be available for inspection by any enforcement officer, upon request.
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