ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
09 March 2007
Application Code
HSC06034
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous Substances
and New Organisms Act 1996 (the Act).
Applicant
Botry-Zen Limited
PO Box 1777
Dunedin
Purpose of the Application
ARMOUR-Zen: to manufacture and conduct field trials of
this substance in containment to test the commercial scale
production system and test its efficacy against Botrytis cinerea
in grapes, kiwifruit, blackcurrants and ornamentals. (Field)
Date Application Received
11 December 2007
Consideration Date
09 March 2007
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to manufacture and trial in containment the hazardous substance,
ARMOUR-Zen (containment), 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
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
ARMOUR-Zen (containment)
1.3
ARMOUR-Zen (containment) is referred to as ARMOUR-Zen within this decision.
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 31. The decision was determined in
accordance with section 32, taking into account matters to be considered in that
section and additional 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 Application process
3.1
The application was formally received on 11 December 2006.
3.2
On 16 January 2007, the applicant was requested, under section 58, to provide further
information on the application.
3.3
This information was received on 26 January 2007 and verified on 29 January 2007.
3.4
Evaluation of the application was undertaken by the ERMA New Zealand project
team which comprised the following staff members:
Brendon Noonan
Advisor (Hazardous Substances)
Chris Geering
Advisor (Hazardous Substances)
Linda Robinson
General Manager (Māori Unit)
Noel McCardle
Senior Advisor (Hazardous Substances).
3.5
The applicant supplied the following documents:
 the application;
 confidential appendices including details on the formulation, the study outline
and study protocol.
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
No responses were received from any of the government departments notified.
3.8
The applicant was provided with a copy of the proposed controls for ARMOUR-Zen
and was given the opportunity to comment on them. The comments received from
the applicant were taken into account when considering this application.
ERMA New Zealand Decision: Application HSC06034
Page 2 of 11
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)).
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 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 manufacture and field trial ARMOUR-Zen in
containment to test the commercial scale manufacturing system and to test the
substance’s efficacy against Botrytis cinerea in grapes, kiwifruit, blackcurrants and
ornamentals.
4.4
The project team 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).
Life cycle
4.5
The applicant, Botry-Zen Limited, intend to manufacture a maximum of five 200250 litre batches of ARMOUR-Zen in their secure Dunedin production facility (total
production between 1,000 and 1,250 litres). The manufacturing process will be carried
out in a closed system that is separated from other factory operations to limit access to
the substance.
4.6
The manufacture of multiple batches of ARMOUR-Zen is intended to test the
production system designed for the substance at a commercial scale. Quantities of the
substance produced, not designated for use in the field trialling, will be packaged in
5 litre containers and will be stored a secure area until the substance is approved for
release. Note: after this approval expires if a release approval has not been granted the ARMOURZen formulation will not be approved and will need to be disposed of.
4.7
Quantities of the substance destined for trialling will be packaged in 1 litre containers
which will be dispatched to the trial sites. The applicant expects that the maximum
quantity of ARMOUR-Zen used in the field trials will be 5 litres. Quantities of the
product for trialling will be stored in secure chemical lockers until required in the field.
4.8
The applicant intends to conduct replicated plot trials at several sites throughout
New Zealand to determine the efficacy of the formulation against Botrytis cinerea.
During the field trialling the substance will be applied using calibrated, ground-based,
spray equipment. Persons trialling ARMOUR-Zen in the field will be experienced in
handling and applying agrichemicals under trial conditions. All use of the substance
will be tracked by the trial directors.
ERMA New Zealand Decision: Application HSC06034
Page 3 of 11
Hazardous properties
4.9
The project team notes that containment applications typically only require a sufficient
understanding of the hazardous properties to ensure that any risks can be managed by
the containment controls.
4.10
The applicant has reviewed the hazardous properties of ARMOUR-Zen and considers
that it triggers the 9.1A classification based on the active ingredient chitosan. The
applicant has provided information that the other ingredients in the ARMOUR-Zen
formulation are reacted and all but neutralised during the substance’s manufacture.
4.11
In terms of human health hazards, the applicant has not identified ARMOUR-Zen as
triggering any. However, as the ARMOUR-Zen formulation has not undergone a full
assessment under HSNO, the project team is not in a position to determine whether or
not the substance poses a risk to human health.
4.12
The project team has reviewed the summary hazard information provided by the
applicant and considers that it is sufficient to determine that any risks posed by the
substance, within its defined life cycle in New Zealand, can be managed through the
imposition of controls.
Identification and evaluation of the significant risks of the substance in
containment
4.13
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the potential risks of
escape from containment have been considered under the headings of environmental,
human health and welfare and Māori issues and concerns.
4.14
The applicant has assessed the potential risks and impacts that may arise from the
contained trialling of the manufacturing process and field trialling of ARMOUR-Zen in
New Zealand. In their assessment, the applicant has also outlined measures to manage
the identified risks and impacts. The project team has reviewed the potential risks and
impacts associated with ARMOUR-Zen in light of the management scheme. This
review is summarised below.
Evaluation of risks to the environment
4.15
As the applicant considers ARMOUR-Zen to be an aquatic ecotoxicant, the project
team considers that adverse environmental effects may result at any stage of the
substance’s life cycle if it were to enter the aquatic environment. However, the project
team notes that chitosan is ubiquitous in the environment as it is present in the shells
of all crustacea and insects and certain other organisms, such as, fungi, algae, and yeast.
Furthermore, the United States Environmental Protection Agency’s (US EPA)
assessment of chitosan considered that it was not expected to pose a risk to the
environment.
4.16
On the basis of the substance’s life cycle, as outlined in paragraphs 4.5 to 4.8, adverse
effects could arise from:
 an incident during manufacture, transportation, storage or field trialling that
results in the substance’s release into the environment
ERMA New Zealand Decision: Application HSC06034
Page 4 of 11


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.
4.17
The project team notes that the volume of the substance to be produced is significant,
in the order of 1000 to 1250 litres. However, only a small proportion of this quantity is
destined for field trialling (approximately 5 litres). The remaining quantity of
ARMOUR-Zen produced in the trial manufacturing runs will be stored in
appropriately designed and managed hazardous chemical storage facility until a full
release approval has been granted. Consequently, the project team considers that the
risks associated with the manufacture of these large quantities of ARMOUR-Zen are
unlikely to be significant and that the risks can be adequately managed by the proposed
controls.
4.18
After taking into account a number of factors the project team considers that risks
posed to the environment from the field trialling of ARMOUR-Zen can be adequately
managed. The factors taken into consideration were the small quantities of the
substance involved in the field trialling, the containment/study regimes proposed by
the applicant, the containment controls proposed, in Appendix 1, and controls
imposed under other legislation
Evaluation of risks to human health and welfare
4.19
In evaluating the risks to human health, the project team notes that no human health
hazard classifications have been identified by the applicant at this time and that there is
a general lack of data regarding most human toxicity endpoints for the active
ingredient. However, the project team notes that the US EPA assessment of the active
ingredient, chitosan, indicates that that they do not expect chitosan to pose a risk to
humans. The project team also notes that chitosan is currently used in pharmaceutical
and weight loss products and has a low toxicity in mice (oral LD50 of 16,000 mg/kg).
On this basis the project team considers that toxicity hazards are unlikely to be present
and are unlikely to occur given the limited number of trial batches being produced and
that the field trials will be of relatively short duration and involve relatively small
quantities of the substance.
4.20
On the basis of the substance’s life cycle, as outlined in paragraphs 4.5 to 4.8, adverse
human health effects could arise from:
 an incident during manufacture, packaging, storage, transportation or field
trialling, resulting in release of the substance and subsequent human exposure
 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 substance from containment.
4.21
In considering the risks posed to human health through the trial production runs and
the subsequent field trialling of ARMOUR-Zen, the project team notes that little
information on hazards has been identified, but also notes that chitosan has a low
acute oral toxicity and is available for human consumption. Taking into consideration
the containment provisions stated by the applicant, the controls proposed in Appendix
ERMA New Zealand Decision: Application HSC06034
Page 5 of 11
1 and controls imposed under other legislation, the project team considers that the
risks to human health can be adequately managed.
Māori issues and concerns
4.22
The project team 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”.
4.23
It is noted that there is limited information available regarding the substance’s hazards.
However, from the information provided, the project team considers that there is
potential for this substance to have a negative impact on Māori and the mauri of iwi,
cultural tāonga and the environment should the substance be released from
containment.
4.24
Taking into consideration the containment measures outlined by the applicant, the
project team considers that any likely impact ARMOUR-Zen 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 project team has no evidence
to suggest that the controlled contained trialling of the substance will breach the
principles of the Treaty of Waitangi and sees no requirement for the applicant to
consult with Māori regarding this application.
4.25
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 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.
5 Containment and controls
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 5b);
 To exclude unauthorized people from the facility (for example, control 16);
 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 25);
 Inspection and monitoring requirements (for example, control 29);
 Qualifications required of the person responsible for implementing the controls
(for example, control 17).
ERMA New Zealand Decision: Application HSC06034
Page 6 of 11
5.2
The Agency considers that, with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, ARMOUR-Zen 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),
“research and development on any hazardous substance”.
6.2
Having considered the risks associated with the life cycle and uncertainties relating to
the hazards of ARMOUR-Zen, I am satisfied that the controls imposed, including
those in place under other legislation, will result in the substance being adequately
contained. I also consider that the controls proposed 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;
 Cause 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 substance, ARMOUR-Zen, is thus approved pursuant to section 32, with
controls as set out in Appendix 1.
Rob Forlong
Date
Chief Executive of ERMA New Zealand
Substance Identifier
ERMA New Zealand Approval Codes
ARMOUR-Zen (containment)
HSC000268
ERMA New Zealand Decision: Application HSC06034
Page 7 of 11
Appendix 1: List of controls that apply to the hazardous
substance ARMOUR-Zen (containment)
Scope
1.
This approval covers:
a.
The contained manufacture of up 1,250 litres of the substance defined as
ARMOUR-Zen (containment) in the application.
b.
The contained storage of ARMOUR-Zen (containment) for the period of this
approval. [Note: after this approval expires if a release approval has not been granted the
ARMOUR-Zen formulation will not be approved and will need to be disposed of].
c.
The contained field trialling of up to 5 litres of ARMOUR-Zen (containment)
per season.
2.
All life cycle 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.
3.
Notwithstanding the requirements of control 2, the manufacture and trialling of
ARMOUR-Zen shall also comply with the following controls.
4.
This approval remains in place for five years from the date of this decision.
Manufacture
5.
The formulation facility used to manufacture the trial batches of ARMOUR-Zen
(containment) shall:
a.
be managed to exclude unauthorised persons from accessing the facility
b.
be managed to exclude unwanted organisms from the facility
c.
provide mechanisms to prevent the unintended release of the substance, for
example secondary containment
d.
have an emergency management plan in place to deal with spillage events.
6.
All persons involved in the manufacture and packaging of ARMOUR-Zen
(containment) shall be appropriately qualified and/or trained in the safe handling of
pesticides.
Packaging and information
7.
The substance 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 Botry-Zen Limited
for storage.
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.
ERMA New Zealand Decision: Application HSC06034
Page 8 of 11
Storage
10.
Quantities of non-field trial ARMOUR-Zen (containment) shall be stored:
a. in a facility that complies with the secondary containment requirements as
specified in regulations 35 to 41 of the Hazardous Substances (Emergency
Management) Regulations 2001
b. securely so that unauthorised persons cannot gain access to the substance;
c. in a manner so as to restrict distribution of the substance to other parties.
11.
Quantities of ARMOUR-Zen (containment) for field trialling shall be stored securely
in accordance with the Code of Practice for the Management of Agrichemicals NZS
8409: 2004.
Transport
12.
The substance 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.
General handling of the substances
13.
Appropriate personal protective equipment (PPE), for example, safety glasses, gloves,
respiratory and protective clothing shall be worn when handling the substance during
manufacture, use and disposal.
Trial Conditions
14.
Access to the trial sites shall be by permission of the Trial Director1, or nominated
researcher.
15.
The trial site boundaries shall be clearly marked and distinctly visible from outside the
trial site throughout the life of the trials.
16.
The trial sites shall be signed indicating that unauthorised access is not permitted, that
the site is subject to a trial, and that fruit or plant matter should not be removed.
17.
During the field trials the substance shall be under the control of experimental staff
who —
a. are experienced in the handling and application of pesticides under test
conditions using the specified equipment
b. have been made aware of the study protocol and the controls in place in
order to adequately manage the substance.
18.
The substance 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.
19.
The substance shall be applied using calibrated ground based spray equipment.
20.
Trials shall be conducted in a manner such as to prevent the substance entering surface
or ground water systems.
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.
1
ERMA New Zealand Decision: Application HSC06034
Page 9 of 11
21.
The trials shall be conducted and managed so as to prevent vertebrates and non- target
invertebrates from coming into contact with the substance throughout the trials.
22.
Trial sites that are at risk of entry by grazing animals shall be secured by stock proof
fencing to exclude animals for the duration of the trial and any stock withholding
periods set by the ACVM Group of the New Zealand Food Safety Authority.
23.
At completion of the trials all treated fruit shall be disposed of in a designated area
within the trial site by burying or mulching in.
24.
A record shall be kept of the use of the substance. This record shall cover all matters
referred to in Regulation 6(1) of the Hazardous Substances (Classes 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
25.
Any spillage of the substance shall:
a. be contained and prevented from entering water bodies
b. be absorbed with an appropriate absorbent material where appropriate. The
absorbent material shall be placed in sealed containers and disposed of
appropriately.
Disposal
26.
Any surplus substance remaining at the end of the trials shall:
a. be returned to Botry-Zen Limited where it will be securely stored along nonfield trial ARMOUR-Zen (containment) stock or
b. be stored in an exempt laboratory that meets the requirements set out in the
Hazardous Substances (Exempt Laboratories) Regulations 2001 for the
purpose of further analysis or until disposed of.
27.
Where disposal is required the substance shall be disposed of in a manner compliant
with the Hazardous Substances (Disposal) Regulations 2001.
28.
Containers no longer used to contain the substance or residue or rinsate from
equipment used to handle the substance shall be disposed of in a manner compliant
with the Hazardous Substances (Disposal) Regulations 2001.
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
ERMA New Zealand Decision: Application HSC06034
ARMOUR-Zen (containment)
HSC06034
HSC000
Brendon Noonan
Page 10 of 11
30.
If for any reason a breach of containment occurs, the Trial Director shall:
a. notify the Department of Labour and ERMA New Zealand within 24 hours
of the breach being detected
b. advise the relevant iwi authority, if the breach of containment results in the
contamination of a waterway.
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 2, notwithstanding its confidential nature, shall be available for
inspection by any enforcement officer, upon request.
ERMA New Zealand Decision: Application HSC06034
Page 11 of 11