ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
11 November 2004
Application Code
HSC04014
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
Crop & Food Research
Purpose of the Application
To trial, in containment, the substance Mitemist
Envirosol® to obtain efficacy and residue data
Date Application Received
12 August 2004
Consideration Date
9 November 2004
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import or manufacture into containment the hazardous substance
Mitemist Envirosol® 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:
Mitemist Envirosol®
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 12 August 2004.
3.2
The application was stalled under section 58 on 17 September 2004 so that the
applicant could provide further information on the relevance of the trial site to Māori,
and unstalled on 1 November 2004.
3.3
Project Team:
Amanda McKenzie
Applications Advisor (Hazardous Substances)
Tania Van Maanen
Advisor (Hazardous Substances)
Zack Bishara
Advisor (Maori Unit)
Report review and sign-out by:
Beth Dye
Programme Manager (Applications, Hazardous
Substances)
3.4
The applicant supplied the following documents:
 The Application
 Confidential appendices, containing compositional information, a Project Plan and a
Management Plan
3.5
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 (ACVM) Group).
3.6
A response was received from:
 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) given that the substance is intended for experimental purposes only.
3.7
The applicant was provided with a copy of the proposed controls for Mitemist
Envirosol® and given the opportunity to comment on them. No comments were
received within the timeframe given.
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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).
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
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.
Purpose of the Application
4.3
The purpose of the application is to trial, in containment, the substance Mitemist
Envirosol® to obtain efficacy and residue data.
4.4
Mitemist Envirosol® is being trialled for its efficacy against varroa mites.
4.5
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
4.6
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.
4.7
The Project Team has assessed the available information and has identified that the
hazardous properties of Mitemist Envirosol® are limited to the following properties:
 Toxicity: 6.3A Skin Irritant, 8.3A Eye Corrosive
 No Ecotoxic thresholds were triggered
 No Physical Hazardous Properties thresholds were triggered
4.8
I have reviewed the applicant’s hazard information and that provided by the Project
Team 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
4.9
Mitemist Envirosol® is a cold fogging pesticide. Non-flammable liquid carbon dioxide
is used to dispense the pesticide formulation that is contained in an industrial cylinder.
Three industrial high-pressure cylinders, each with a capacity of 6 kg, will be prepared
for the trial and stored at Crop & Food Research’s Research Laboratory, Palmerston
North. Storage will be in a secured compound, with open ventilation.
4.10
At the start of the trials, the cylinders will be removed from storage and transported by
an approved transporter to the Research Apiary at the Aorangi Research Station in the
Manawatu.
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4.11
The required quantity of Mitemist Envirosol® will be applied to the entrance of each
hive before honey supers are added to the hives at the beginning of the honey flow.
The entrance of each hive will be blocked during and immediately after treatment.
4.12
The active ingredient used in Mitemist Envirosol® is Thyme oil, of which Thymol is
the principal biocidal component. The applicant states that Thyme oil is listed as a
GRAS (generally regarded as safe) compound with the ACVM Group and further notes
that Thymol is exempt from the Maximum Residue Limits of Agricultural Compounds,
set by the New Zealand Food Safety Authority. As such, the applicant proposes to sell
any honey harvested from the treated hives, provided the residue levels are below the
sensory threshold of 1.1ppm. Honey with residues above this threshold will be
disposed of in an approved sanitary landfill.
4.13
Any surplus formulated substance will be stored in approved steel compressed gas
cylinders at the Envirosol Research Laboratory.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.14
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.
4.15
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 risks and agree that it is suitable for the consideration below.
Risks to the Environment
4.16
The ecotoxicological data available indicates that Mitemist Envirosol® does not trigger
any of the ecotoxicity thresholds.
4.17
The applicant’s containment regime includes a number of factors which reduce any risk
to the environment. They include:
 Mitemist Envirosol® will be stored securely in approved steel compressed gas
cylinders at the Envirosol Research Laboratory at Crop & Food Research
 Mitemist Envirosol® will be applied as a fog through hive entrances, which will be
block during and immediately after treatment
4.18
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
4.19
Contact of the substance with eyes or skin may result in adverse effects on human
health and welfare.
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4.20
On the basis of the lifecycle of the substance outlined in paragraphs 4.9 – 4.13, adverse
effects on human health and welfare could arise from:
 An accident, resulting in exposure to the substance during import, storage, use or
transportation.
4.21
The applicant’s containment regime includes a number of factors that reduce the risk to
human health and welfare. They include:
 The use of protective clothing and equipment in the risk area, including a full face
respirator with appropriate canister and coveralls
 Treatment will be in accordance with Section 5 of NZ 8409:2004 Code of Practice
for the Management of Agrichemicals
4.22
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
4.23
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”.
4.24
I note that Tanenuiarangi Manawatu Incorporated, the mandated Iwi authority for
Rangitaane O Manawatu has reviewed the application made to ERMA New Zealand,
specifically in relation to the Aorangi Research Station trial site and any “risks
associated with the relationship to Maori and their culture”. Tanenuiarangi Manawatu
Incorporated states that they are happy to see that the research being conducted requires
approval from ERMA New Zealand and would expect that the controls described in the
application are followed to prevent any damage to the environment. If any unintended
release to the surrounding environment did occur the Tanenuiarangi Manawatu
Incorporated should be notified in accordance with control 17.
4.25
On the basis of the information provided by the ERMA New Zealand Advisor (Māori
Unit) and the letter received from Tanenuiarangi Manawatu Incorporated, 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.
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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

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

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To limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances (for example, control 3)
To exclude organisms from a facility (for example, control 6)
To exclude unauthorized people from the facility (for example, control 5)
To prevent unintended release of the substances by experimenters working with the
substance (for example, control 4)
To control the effects of any accidental release of the substance (for example,
control 5)
Inspection and monitoring requirements (for example, control 17)
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, the substance can be adequately contained.
6
Decision
6.1
I have considered this application under section 31 to import or manufacture 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 Mitemist Envirosol®, 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 or manufacture into containment the hazardous substance
Mitemist Envirosol® is thus approved pursuant to section 32 of the Act, with controls
as set out in Appendix 1.
Bas Walker
Date 11 November 2004
Chief Executive of ERMA New Zealand
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ERMA New Zealand Approval Code:
Mitemist Envirosol®: HSC000127
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Appendix 1: List of controls that apply to the
hazardous substance Mitemist Envirosol®
1. The trials shall be undertaken in accordance with the Management Plan provided with the
application. Modifications of the procedures 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 Trial Director1 shall ensure that Mitemist Envirosol® is applied through the hive
entrances which shall be blocked during and immediately after treatment.
4. The relevant provisions of the Hazardous Substances (Compressed Gas) Regulations
2004 shall be complied with.
5. Access to the trial sites shall be by permission of the Trial Director. The trial site
boundaries shall be clearly marked and distinctly visible from outside the trial site
throughout the life of the trial. The trial site shall be signed indicating that unauthorized
access is not allowed, that the site is subject to a trial, and that the hives should not be
removed or disturbed.
6. Where it is possible for grazing animals to access the trial site, the trial site shall be
secured by stock proof fencing to exclude grazing animals for the duration of the trial.
7. The substance shall be prepared in accordance with the relevant sections of the Code of
Practice for the Management of Agrichemicals NZS8409.
8. The substance shall be stored in a secure storage facility at Crop & Food Research,
Palmerston North.
9. The substance shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001.
10. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 1999.
11. All personnel in the trial area during treatment shall be required to wear full protective
clothing including a suitable respirator or self-contained breathing apparatus.
12. Any unused substance remaining at the end a trial shall be returned to the Crop & Food
Research Facility for secure storage. (Note that once the trials are completed Mitemist
Envirosol® does not have approval to be present in New Zealand except in an exempt
laboratory).
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 details included in the application and with the approval controls.
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13. 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.
14. 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.
15. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
location, start, and completion of the trials. The OSH project manager shall be informed
by fax or email at least three working days prior to application at specific sites.
16. 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, Tanenuiarangi
Manawatu Incorporated be advised.
17. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
18. 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.
19. The maximum quantity of Mitemist Envirosol® that shall be manufactured under this
approval is 18 kg.
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