ENVIRONMENTAL RISK
MANAGEMENT AUTHORITY DECISION
24 October 2006
Application Code
HSC06026
Application Type
To import and manufacture hazardous substances in
containment under Section 31 of the Hazardous
Substances and New Organisms Act 1996 (the Act)
Applicant
Biosecurity New Zealand
Purpose of the Application
To test substances containing imidacloprid, fenitrothion,
bifenthrin and diazinon for their ability to kill feral bees
infected with the Varroa mite
Date Application Received
16 October 2006
Consideration Date
24 October 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
SUMMARY OF DECISION
1.1
The application to import and manufacture in containment hazardous substances
containing imidacloprid, fenitrothion, bifenthrin and diazinon is approved with
controls in accordance with the relevant provisions of the 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:
substances containing imidacloprid, fenitrothion, bifenthrin and diazinon
(HSC06026)
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 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
APPLICATION PROCESS
3.1
The application was formally received on 16 October 2006.
3.2
Project Team:
Noel McCardle
Senior Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Robinson
Group Manager (Māori Unit)
Report review and sign-out by:
Peter Dawson
Principal Scientist (Hazardous Substances)
3.3
The applicant supplied the following document:
 the application, including a protocol for the containment study.
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 ACVM Group of the New Zealand Food Safety Authority; and
 The Department of Conservation.
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for the substances
containing imidacloprid, fenitrothion, bifenthrin and diazinon and given the
opportunity to comment on them. No response was 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)).
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.
ERMA New Zealand Decision: Application HSC06026
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Purpose of the application
4.3
In an attempt to eliminate the Varroa bee mite from the South Island the applicant has
established an eradication zone in the Nelson region. As part of the eradication
programme the applicant wants to develop a substance that is suitable for killing feral
bees.
4.4
The purpose of the application is to import and manufacture in containment,
substances containing imidacloprid, fenitrothion, bifenthrin and diazinon for the
purpose of testing their ability to kill feral bees infected with the Varroa mite.
4.5
The technical grade active ingredients have HSNO approval for use in the
manufacture of pesticides. The applicant proposes to prepare bait solutions from the
technical grade active ingredients or from substances that contain these active
ingredients that have been previously approved by ERMA New Zealand. However, as
these substances have been approved with a restriction on their use in situations where
bees may be exposed, a containment approval is required before they can be used in
trials designed to assess their efficacy in killing bees.
4.6
As the purpose amounts to “research and development on any hazardous substance”,
the Agency considers that the application qualifies for consideration under section
30(ba).
Life cycle
4.7
The applicant advises that between one and five litres of each of the substances will be
imported and transported into a laboratory environment at the HortResearch
laboratory at Ruakura.
4.8
The candidate substances will be screened for efficacy, and to determine oral lethal
doses for bees, using caged honey bees in the laboratory and full colonies that are
trained to visit a bait station in a flight cage at the Ruakura Research Centre in
Hamilton.
4.9
The selected substances will be transported to Nelson and field tested in an area from
which all hives (both managed and feral bee hives) have been removed. This study area
will be part of the “eradication zone” that has been established in the Nelson area. The
eradication zone is an area from which it is intended to remove all managed and feral
bee colonies.
4.10
In the Nelson study area, ten colonies will be placed in an area of less than one hectare.
Two litres of sugar syrup will be placed in a bait station in the centre of the group of
hives. The bait station will be sprayed with honey. When more than 500 bees are
foraging at the bait station the sugar syrup will be replaced with sugar syrup containing
s small amount of the selected candidate substance. The poisoned syrup will be
replenished until foraging ceases.
4.11
If all the colonies have not been killed the bait station will be refilled with syrup and
sprayed with a honey solution and the poisoning process will be repeated. This will be
repeated three times if necessary. The frames in any dead colonies will be removed
and burnt.
ERMA New Zealand Decision: Application HSC06026
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4.12
If the selected substance does not effectively kill honey bee colonies in the field then
this process will be repeated using one of the other suitable substances.
4.13
At the end of the study period the residual bait will be collected into waste containers,
and the empty bait stations will be placed in marked bags and returned to
HortResearch. The waste bait will be incinerated at a registered facility. The bait
stations will be cleaned and stored for re-use or disposal. The dead bees around the
bait stations and the frames in any dead colonies will be removed and burnt. Any
hives still alive at the end of the study will also be killed and the frames removed and
burnt.
4.14
Any surplus substance remaining after completion of research work will be stored in
the HortResearch laboratory at Ruakura until it can be disposed of safely.
Hazardous properties
4.15
It is noted that a containment application requires only sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls.
4.16
As the substances have been approved under the Act, the applicant has been able to
identify their hazardous properties.
4.17
The Agency has reviewed the hazard information and considers that there is sufficient
information to determine that any risks posed by the substances can be managed by
the containment controls.
Identification and evaluation of the significant risks of the substance
in containment
4.18
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the potential risks of
escape from containment under the headings of environmental, human health and
welfare and Māori issues and concerns were considered.
4.19
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of risk management. The Agency has reviewed the
applicant’s assessment of risks and agrees that that it is suitable for the consideration
below.
Risks to the environment
4.20
The hazardous properties of the substances indicate the potential for harm to be
caused to organisms in the aquatic environment, the soil environment and to terrestrial
vertebrates and invertebrates exposed to the substances.
4.21
The applicant identified the following risks to the environment as being potentially
significant:


risk to environment from spillage; and
risk to non-target species.
ERMA New Zealand Decision: Application HSC06026
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4.22
The applicant advises that any spills on a hard surface will be treated by absorption and
incineration and any laboratory waste will not enter waterways.
4.23
Any spillage of the field strength substance or trial bait solution will be mopped up
using shredded paper where possible, followed by removal of 10cm of the underlying
soil to remove any residues from the site. The shredded paper and soil will be double
bagged and transported back to the HortResearch for disposal by incineration at a
registered facility.
4.24
Used bait stations will be returned to the HortResearch laboratory for cleaning and
storage for re-use within the Varroa Nelson programme. At the conclusion of the
programme, they will be destroyed by incineration. Waste trial bait solution and
containers, and any contaminated soil will be incinerated. Used gloves and disposable
overalls will be incinerated; any contaminated clothing will be laundered. Boots will be
detergent washed. Waste water from the boot cleaning will enter the Nelson city
municipal waste stream.
4.25
Taking into account the properties of the substances, the quantities involved, the
containment regime proposed by the applicant, the containment controls specified in
Appendix 1 and controls in place under other legislation, the Agency considers that
there are no significant risks to the environment.
Risks to human health
4.26
As the substances possess a range of toxic properties, they have the potential to
adversely affect human health in the event of exposure(s).
4.27
The applicant identified the following risks to human health as being potentially
significant:



risk to workers (occupational safety);
risk to public from bait stations; and
risk to public health from spillage.
Risk to workers
4.28
The laboratory staff may be exposed to the substances containing the active
ingredients during the manufacture of the stock bait solution for the laboratory trials.
4.29
The applicant advises that the stock bait solution is planned to contain less than 0.1%
active ingredient and that the laboratory where the stock bait solution is formulated
will have standard operating procedures for the handling of hazardous substances. The
process of manufacturing the stock bait solution will be undertaken by trained staff
within the HortResearch laboratory specified. All chemical storage and manipulation in
the laboratory will be completed following good laboratory practice, recommended
safety procedures, chemical specific requirements as detailed on SDS literature, and
standard laboratory operating procedures for chemical management and manipulation.
The HortResearch laboratory is certified by IANZ and operates under ISO 17025
guidelines. As such the practices for safe handling of chemicals are documented and
further enhanced by HortResearch's Safety Policy for the handling of chemical,
biological and radioactive materials.
ERMA New Zealand Decision: Application HSC06026
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4.30
The applicant advises that field study staff will be briefed on the use and safety
precautions each morning by the study director.
4.31
The trial personnel will wear approved personal protective equipment (PPE) to reduce
dermal exposure and the field staff are experienced in the running of similar trials to
poison bees. Field trial teams will have adequate personal protective equipment, bags,
and paper towels to mop up minor spills of approved chemicals.
4.32
Any spillage involving personal protective equipment will be removed using
absorption on a paper towel. Contaminated towels and PPE will be disposed of by
incineration. In the unlikely event of any trial personnel receiving exposure to these
chemicals orally or via the eye or skin, they will seek medical attention without delay.
Risk to public from bait stations
4.33
The bait stations will be sited where the public does not have access to them.
Landowner permission will be obtained before stations are sited on private land. Field
teams will be carefully instructed on the placement of bait stations, and will constantly
monitor them while toxic baits are present. Warning signs will be put in place prior to
use.
4.34
Bait stations will be checked several times per day while pre-baiting with sugar syrup.
Once bee foraging has ceased (due to death of the bee colonies), any remaining toxic
solution will be removed and stored securely for disposal as hazardous waste. Under
no circumstances will any toxic solution be left in bait stations overnight.
Risk to public health from spillage
4.35
As discussed above, any spillage of the field strength substance or trial bait solution
will be mopped up and disposed of by incineration at a registered facility.
Overall assessment of risk to human health
4.36
Taking into account the properties of the substances, the quantities involved, the
containment regime proposed by the applicant, the containment controls specified in
Appendix 1 and controls in place under other legislation, the Agency considers that
there are no significant risks to human health.
Risks to human welfare
4.37
The applicant identified the following risks to human welfare as being potentially
significant:




risk to managed colonies inside the study area
risk to managed colonies immediately outside the study area
risk from honey from feral colonies inside the study area
risk from honey from feral colonies immediately outside the study area.
ERMA New Zealand Decision: Application HSC06026
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Risk to managed colonies in the study area
4.38
The applicant considers that this risk is very low because few, if any, managed hives
remain in the eradication zone and hives specially supplied for the study will be placed
in close proximity to the bait station ensuring that the majority of the poison goes to
these hives. Because all registered hives have been removed, if any hives did remain
they would be for domestic pollination or production of honey for personal
consumption rather than for honey for commercial sale. However, as there will be no
working hives in the study area, the risks of poisoning managed colonies is considered
to be insignificant.
Risk to managed colonies immediately outside the study area
4.39
The study site selected will have a significant buffer zone around it where there are no
managed hives.
4.40
Beekeepers have been advised that poisoning operations are underway, and to move
their hives until they are more than 5km from the eradication zone. Beehives normally
forage on the sources of nectar and pollen closest to their hive. It is unlikely any bees
will fly over 5km to forage and thus the risks to managed colonies outside the study
area are insignificant.
Risk from honey from feral colonies inside the study area
4.41
The primary target of the poisoning programme is feral colonies inside the eradication
zone, which are likely to be infested with varroa. In the study area all the feral colonies
that can be found will be destroyed prior to the study being started.
Risk from honey from feral colonies immediately outside study area
4.42
The placement of the study bait stations will allow for a buffer area inside the zone
boundary. Because of the restricted range of foraging it is very unlikely that bees
immediately outside the study area could visit bait stations in the study area.
Overall assessment of risk to human welfare
4.43
Taking into account the properties of the substance, the quantities involved, the
containment regime proposed by the applicant, the containment controls specified in
Appendix 1 and controls in place under other legislation, the Agency considers that
there are no significant risks to human welfare.
Māori issues and concerns
4.44
The applicant advised that consultation with the Māori strategy group within MAF did
not identify any significant issues of concern to Māori. A representative of local iwi
was strongly supportive of the eradication of varroa from the South Island.
4.45
The project team is also unaware of any impacts that the substances could have on
Māori culture, or, on traditional relationships with ancestral lands, water, sites, wāhi
tapu, valued flora and fauna or other taonga. There is no evidence to suggest that the
use of the substances will breach the principles of the Treaty of Waitangi and the
Agency sees no requirement for the applicant to consult with Māori regarding this
application.
ERMA New Zealand Decision: Application HSC06026
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4.46
5
This assessment is made on the condition that the substances are manufactured,
handled, 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 recommended 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.
CONTAINMENT AND CONTROLS
5.1
The Agency has evaluated the adequacy of the containment arrangements proposed by
the applicant and the controls listed in Appendix 1, and considers 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 substance or
contamination by hazardous substances (for example, control 6);
 to exclude organisms from a facility (for example, control 10);
 to exclude unauthorized people from the facility (for example, control 12);
 to prevent unintended release of the substance by experimenters working with the
substance (for example, control 15);
 to control the effects of any accidental release of the substance (for example,
control 17);
 inspection and monitoring requirements (for example, control 20); and
 qualifications required of the person responsible for implementing the controls
(for example, control 13).
5.2
The Agency is satisfied that, with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, that the substances 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 a purpose specified in section 30(ba) ie for
purposes of “research and development” on substances containing imidacloprid,
fenitrothion, bifenthrin and diazinon.
6.2
Having considered the risks associated with the lifecycle of substances containing
imidacloprid, fenitrothion, bifenthrin and diazinon, I am satisfied that the controls
imposed, including those in place under other legislation, will result in the substances
being adequately contained. Further, I consider that the controls applied 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;
ERMA New Zealand Decision: Application HSC06026
Page 8 of 12

6.5
clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
The application to import, manufacture and field trial, in containment, the substances
containing imidacloprid, fenitrothion, bifenthrin and diazinon is thus approved pursuant to
section 32, with controls as set out in Appendix 1.
Rob Forlong
Date 24 October 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
substances containing imidacloprid, fenitrothion, bifenthrin and diazinon:
ERMA New Zealand Decision: Application HSC06026
HSC000250
Page 9 of 12
Appendix 1: List of controls that apply to the hazardous
substances containing imidacloprid, fenitrothion, bifenthrin
and diazinon
General
1.
This approval covers the laboratory screening and field trialling of substances containing
imidacloprid, fenitrothion, bifenthrin and diazinon to assess efficacy in killing feral bees.
2.
The importation, manufacture and trials shall be undertaken in accordance with the
protocol which accompanied the application. Modification of the protocol may be
approved in writing by ERMA New Zealand provided that those modifications comply
with the following controls.
3.
Notwithstanding the requirements of control 1 above, the manufacture and trialling of the
substances shall comply with the following controls:
Packaging and Information
4.
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
5.
Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001. The label must also set out instructions that any of the substance
remaining after each trial must be returned in its original container to HortResearch.
6.
A Safety Data Sheet, compliant with the Hazardous Substance (Identification) Regulations
2001, shall accompany each shipment of the substance and be held at each trial site for the
duration of the trial.
Storage
7.
The substances shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004, ie be locked in facilities where access is
restricted to authorised persons only.
Transport
8.
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.
General handling of the substances
9.
Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substances, for example during manufacture,
handling, application and disposal.
Trial Conditions
10.
Baits shall be laid in accordance with the specified trial protocol.
ERMA New Zealand Decision: Application HSC06026
Page 10 of 12
11.
A record shall be kept of all use of the substances. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Classes 6, 8, and 9 Controls)
Regulations 2001.
12.
Access to the study area shall be by permission of the Trial Director1, nominated
researcher or owner of the property on which it is located. The study area shall be clearly
marked and distinctly visible throughout the life of the trials. The study area shall be
signed indicating that unauthorised access is not permitted, that the site is subject to a trial,
and that the bait stations and hives are hazardous and should not be removed or disturbed.
13.
During use, the substance shall be under the control of study staff, who are trained and
experienced in the handling and laying of pesticidal agents under test conditions using the
specified equipment. The study staff should also be aware of the study protocol and the
controls in place in order to adequately manage the substances.
14.
The substances shall be mixed, diluted, prepared or otherwise handled in accordance with
the relevant sections of the Code of Practice for the Management of Agrichemicals NZS
8409: 2004.
15.
After application, any equipment used in the trial shall be disposed of in an appropriate
manner or be cleaned with the residue and/or rinsate being treated in a manner so that it is
no longer hazardous. The bait stations may be re-used within the Varroa Nelson
programme.
16.
Waste trial bait solution and containers shall be incinerated. Surplus substance remaining at
the end of the trials shall be stored in the HortResearch laboratory or disposed of
according to the Hazardous Substances (Disposal) Regulations 2001.
Emergency Management
17.
Any accidental spillage of the substances or bait shall be contained, prevented from
entering waterways and be recovered using appropriate equipment and materials.
Contaminated material shall be placed in sealed containers and disposed of at an
appropriate waste disposal facility (which may include a landfill), subject to the facility’s
waste acceptance policy. Any equipment used shall be cleaned with any residues or rinsate
being disposed of in accordance with the disposal requirements.
Notification and Inspection
18.
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
substances containing imidacloprid, fenitrothion,
bifenthrin and diazinon
HSC06026
HSC000250
Noel McCardle
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 HSC06026
Page 11 of 12
19.
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.
20.
The Authority or its authorised agent or properly authorised enforcement officers may
inspect the facilities and trial sites at any reasonable time. Trial documentation,
notwithstanding its confidential nature, shall be available for inspection by any
enforcement officer, upon request.
ERMA New Zealand Decision: Application HSC06026
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