ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
8 March 2007
Application Code
HSC07004
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (the Act)
Applicant
Sarah Weston
Bayer New Zealand Ltd.
PO Box 2825
Auckland
Purpose of the Application
CheckMite+: To approve local trial work to confirm the efficacy,
safety and residue profile of CheckMite+ under New Zealand
beekeeping conditions (field trial)
Date Application Received
14 February 2007
Consideration Date
7 March 2007
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to import into containment the hazardous substance, CheckMite+, 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:
CheckMite+
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.
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3 Application process
3.1
The application was formally received on 14 February 2007.
3.2
Evaluation of the application was undertaken by the ERMA New Zealand Project
team which comprised the following staff members:
3.3
Bella Whittle
Advisor (Hazardous Substances)
Chris Geering
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit
Noel McCardle
Senior Advisor (Hazardous Substances)
The applicant supplied the following documents:
 the application;
 a confidential appendix, including the identification of the substance, a list of
substance impurities, a hazard classification, and a copy of the trial protocol.
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 Department of Labour (Workplace Group);
 the New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group));
 the Department of Conservation (DOC) (Research, Development and
Improvement Division).
3.5
A representative of DOC commented that they see no problems with what is requested in
the application in terms of potential impacts to New Zealand biodiversity values, taking
into consideration the localised impacts of the impregnated strips.
3.6
A representative of the ACVM Group commented that residues are a matter of concern,
and that the wider residue risk will specifically be considered by the ACVM. Further
comments were made regarding the likelihood of robbing behaviour by external bees given
the buffer zone in place.
3.7
The applicant was provided with a copy of the proposed controls for CheckMite+ and
given the opportunity to comment on them. The comments provided were taken into
account in the setting of controls.
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
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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
CheckMite+ is an acaricide for the control of the Varroa mite, an external parasite of
adult and developing honey bees.
4.4
The purpose of the application is to conduct local trial work to confirm the efficacy,
safety and residue profile of CheckMite+ under New Zealand beekeeping conditions.
Further, the research will contribute to the acquisition of information for use in
assessing CheckMite+ for a HSNO approval for release.
4.5
As the purpose amounts to “research and development on any hazardous substance”,
the project team considers that the application qualifies for consideration under section
30(ba).
Life cycle of the substance
4.6
The applicant advises that the substance CheckMite+ will be dealt with throughout its
life cycle in New Zealand in the following way:

60 strips of the substance will be imported into New Zealand. The substance
will initially be stored at the facilities of Bayer New Zealand at Hillcrest,
Auckland.

the substance will then be transported directly to the trial investigator at the trial
site. The trials will be conducted at the Bee Research Facility on the
HortResearch campus at Ruakura, Hamilton. Entry to the campus is by swipe
card access only. The apiaries to which the substance will be applied are behind
additional locked gates. Unauthorised people will not have access to the trial site.

the trial investigator will use the substance according to the trial protocol, as
provided with the application in the confidential material. The substance will be
accounted for at the beginning and end of the trials.

the substance will be applied to beehives, which are isolated from other apiaries
by at least 2 km. Once the product is removed from the hive after sufficient
amount of treatment time, both the remaining product and the hive ware with
which it has been in contact will be destroyed.

any remaining substance left over after the completion of the trials will be
returned to the Hillcrest office of Bayer New Zealand and either re-exported or
destroyed.
Hazardous properties
4.7
The project team notes that a containment application only requires sufficient
understanding of the hazardous properties to ensure that any risks can be managed by
the containment controls. The scope of the hazard information will often be limited
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for containment applications, as the substance will be experimental and may not be
commercialised.
4.8
The applicant has examined the hazardous nature of CheckMite+ and considers it to
be acutely toxic by inhalation or ingestion (6.1C), irritating to the eye (6.4A), toxic to
human target organs or systems (6.9A), ecotoxic in the aquatic environment (9.1A),
and ecotoxic to terrestrial vertebrates (9.3A).
4.9
The project team has reviewed these classifications and other information supplied by
the applicant and considers that the information is sufficient to determine that any
risks posed within the defined life cycle of the substance in New Zealand can be
managed through the application of controls.
Identification and evaluation of the significant risks of the substance in
containment
4.10
The applicant has identified and assessed potential risks and detailed proposals for, and
impacts of, risk management. The project team has reviewed the applicant’s
assessment of the risks to the environment, to human health and safety and to Māori
cultural wellbeing as set out below.
Risks to the environment
4.11
If released into the environment the substance has the potential to result in adverse
effects. Given the hazard classifications, such exposure may adversely impact aquatic
organisms or terrestrial vertebrates. The project team considers that the substance
may also affect non-target bees and hive products if exposure to these bees and/or
subsequent contamination to external hives were to occur.
4.12
On the basis of the life cycle of the substance, adverse environmental effects could
arise from:
 an accident during storage, use or transportation, resulting in release of the
substance;
 failure to follow the correct operational procedures as set out in the controls and
containment system as described in the application, resulting in release of the
substance;
 escape of treated bees from the facility or the access of non-target bees or other
invertebrates to the treated hives, resulting in adverse effects to organisms or
subsequent contamination of honey, wax or propolis in hives external to the trial
site;
 failure to follow correct disposal procedures, resulting in release of the substance.
4.13
The project team considers the risk of adverse effects to non-target organisms, or
contamination of hives surrounding the trial site with the active ingredient in
CheckMite+ to be the most potentially significant risks. The project team noted the
substance will be presented in the form of a strip, which is applied within the treated
hives only and food resources will be made available to bees outside the containment
area to ensure that robbing behaviour is not elicited. In addition, the bee colonies to
which the trials are subject will be isolated from other apiaries by at least 2 km. Given
such provisions, the project team considers that exposure of external bees to the
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substance will be minimal, and therefore, that it is unlikely that hive contamination and
adverse effects to non-target bees will occur.
4.14
The project team notes that the risk of residues in hive products will be assessed by the
ACVM Group, so this risk is not considered further here.
4.15
The project team considers that the contained import and trialling of CheckMite+ will
not pose any significant risks to the environment throughout the remainder of the life
cycle proposed by the applicant. This assessment is based on consideration of the
containment regime proposed by the applicant, the limited quantity of the substance
involved (60 strips), the controls set out in Appendix 1 and the requirements of other
legislation.
Risks to human health and welfare
4.16
The project team considers that adverse effects to human health and welfare may
result from exposure to the substance. These risks relate to the acute toxicity of the
substance, its potential to cause toxicity to target organs or systems, and its irritancy to
eyes.
4.17
On the basis of the life cycle of the substance outlined in paragraph 4.6, adverse effects
could arise from:
 an accident during storage, use or transportation, resulting in release of the
substance;
 failure to follow the correct operational procedures as set out in the controls and
the containment system, resulting in personnel exposure while contained, or
bystander exposure if released; or
 failure to follow correct disposal procedures.
4.18
The applicant has indicated that the substance has an oral LD50 of 140 mg/kg. The
project team notes that this means that the substance could have potentially serious
consequences if consumed, especially for a child. The applicant advises that the form
of the product as an impregnated plastic strip, packaged within an aluminium sachet,
will increase the difficulty of a child opening and ingesting the product. Given the
containment controls in place, and noting that only trained trial staff have access to the
substance, the project team considers the risk of acute oral toxicity to be highly
unlikely to occur during the trial. The project team considers it infeasible that acute
toxic effects would be incurred by inhalation given the presentation of the substance as
a plastic strip.
4.19
The project team notes that the active ingredient in CheckMite+ may cause target
organ damage, particularly neurotoxicity, through single or repeated exposure. Given
the controlled nature and short duration of the trials, the physical form of the product,
and the protective equipment worn by trial staff (including gloves), the applicant and
project team consider that the likelihood of exposure resulting in neurotoxic effects
will be minimal.
4.20
CheckMite+ may also cause eye irritation, if exposed to the eye. The project team
notes that such irritation, if it occurs, is likely to be short term and temporary. Further,
given the containment provisions required, it is considered that the likelihood of such
exposure will be minimal.
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4.21
The project team considers that there are no significant risks to human health and
welfare, given the quantities involved, the containment regime proposed by the
applicant, the containment controls in Appendix 1 and controls in place under other
legislation.
Māori issues and concerns
4.22
The project team has considered this application in accordance with clauses 9(b)(i) and
9(c)(iv) and sections 6(d) and 8. In addition, the project team used the framework
contained in the ERMA New Zealand user guide “Working with Māori under the
HSNO Act 1996” to assess this application.
4.23
The project team has noted that standard and suggested controls proposed for this
containment field trial will mitigate any risks to negligible levels.
4.24
From the information provided, and considering that the application is for a
containment trial, the project team considers that it is unlikely to have an impact on
the relationship between Māori culture and their traditions with their ancestral lands,
water, sites, waahi tapu, valued flora and fauna and other taonga. This is on the
condition that the substance is used in accordance with the HSNO controls
established for this application, and in accordance with any other relevant controls
applying under other legislation.
4.25
In addition, the trial of this substance does not involve significant community
exposure or significant exposure to the environment, so the project team considers
that there is no requirement for the applicant to consult with Māori regarding this
application.
4.26
However, should inappropriate or accidental use, transport or disposal of the
substance result in the contamination of waterways, it is suggested that the applicant
notify the appropriate authorities including the relevant iwi authorities in the region.
This action should include advising them of the contamination and the measures taken
in response.
5 Containment and controls
5.1
The project team has evaluated the adequacy of the containment arrangements
proposed by the applicant and the controls listed in Appendix 1, and notes 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 substances or
contamination by hazardous substances;
 to exclude organisms from a facility;
 to exclude unauthorized people from the facility;
 to prevent unintended release of the substances by experimenters working with the
substance;
 to control the effects of any accidental release of the substance;
 inspection and monitoring requirements; and
 qualifications required of the person responsible for implementing the controls.
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5.2
The project team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, CheckMite+ can be adequately
contained.
6 Decision
6.5
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).
6.2
Having considered the risks associated with the lifecycle of CheckMite+, 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), 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 substances;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
The application to import into, or manufacture in, containment the hazardous substance
CheckMite+ is thus approved pursuant to section 32, with controls as set out in Appendix
1.
Rob Forlong
Date: 8 March 2007
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCE, CHECKMITE+
General
1. The trials shall be undertaken in accordance with the trial protocol and information on the
proposed containment system provided under section four of the application addressing
matters to be considered under Part III of Schedule 3 of the Act. Modifications of these
specifications may be approved in writing by ERMA New Zealand providing that they
comply with the following controls.
2. 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.
3. This approval applies only to the application of CheckMite+ as an impregnated strip to be
placed directly in bee hives.
4. Notwithstanding the requirements of control 1 above, the importation of CheckMite+ and
trials shall also comply with the following controls:
Import
5. Bayer New Zealand may import a maximum of 60 strips of CheckMite+ under this approval.
Packaging and Information
6. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
7. Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001.
8. The label must also set out instructions that any of the substance remaining after the trial
must be dealt with in a manner compliant with the disposal provisions of these controls (i.e.
control 24).
9. 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 application.
Storage
10. The substance shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004 while not in use or being transported.
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Transport
11. 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 Substance
12. Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substance, for example during handling,
application and disposal.
Trial Sites
13. The trial sites shall be located to prevent any residential area which is not related to the
research from being exposed to the substance.
14. The trial sites shall be isolated from any other apiary by at least 2km. Food sources shall be
available to prevent robbing behaviour by other bees.
15. Access to the trial sites shall be by permission of the Trial Director1 (or trial investigator),
nominated researcher or owner of the property on which it is located. The trial sites shall be
signed indicating that unauthorised access is not permitted, that the site is subject to a trial,
and that the trial animals (bees) should not be removed from the facility.
Trial Conditions
16. During use the substance shall be under the control of experimental staff at the
HortResearch Bee Research Facility at Ruakura, who are trained and experienced in the
handling and administration of acaricides under test conditions using the specified
equipment. Experimental staff should also be aware of the trial protocol and the controls in
place in order to adequately manage the substance.
17. Prior to application, the substance shall be handled in accordance with the relevant sections
of the Code of Practice for the Management of Agrichemicals NZS 8409: 2004.
18. The substance shall be applied to apiaries in accordance with good practice. This would
generally be achieved through compliance with the Code of Practice for the Management of
Agrichemicals NZS8409:2004 or a Standard Operating Procedure retained as part of the trial
records of the party conducting the trial.
19. Any remaining product left over at the completion of the trial shall be removed from the
hive and stored immediately until it is disposed of according to the disposal controls detailed
within this document.
20. No treated honey, wax or propolis shall be consumed by people or (so far as is reasonably
practicable) animals or be sold, offered for sale, given away, bartered or otherwise distributed
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with the Trial Protocol and approval controls.
1
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unless the ACVM Group has approved this process as part of a provisional registration or
research permit.
21. A record shall be kept of all use of the substance. 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.
22. Any equipment or hive-ware used during application of the product shall be treated with an
appropriate detergent or decontaminant until rendered non-hazardous, or disposed of in
accordance with the disposal provisions of these controls.
Emergency Management
23. Any strip of CheckMite+ that is accidentally released from its packaging shall be contained,
prevented from entering water bodies, and be placed within a sealed container (during
transport), stored within the containment area, and finally disposed of (or used in the trials).
Measures should be taken to ensure that no residue from the substance remains on
accidentally exposed surfaces. Any material used to clean the surface exposed to the
substance shall be collected and placed in sealed containers for disposal at an appropriate
waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance
policy.
Disposal
24. At the completion of the trials, any surplus substance remaining at the end of the trials may
be dealt with in the following ways:
 securely stored within the trial facilities for the purpose of further analysis (until the
expiry of this approval) until it can be suitably disposed of;
 securely stored in a laboratory complying with the requirements set out in the Hazardous
Substances (Exempt Laboratories) Regulations 2001;
 treated in a manner to render the substance, as a whole, non-hazardous;
 disposed of in a manner compliant with the Hazardous Substances (Disposal)
Regulations 2001. This includes export from New Zealand as a hazardous waste.
 re-exported, so long as receipt of CheckMite+ in the receiving country complies with
that country’s regulatory requirements.
25. Packages no longer used to contain the substance, residue or rinsate from equipment or hive
ware, or materials for cleaning exposed surfaces shall be disposed of in a manner compliant
with the Hazardous Substances (Disposal) Regulations 2001.
26. After the completion of the trials all treated bees and apiaries shall be contained within the
trial site or destroyed.
Notification and Inspection
27. 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:
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Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
CheckMite+
HSC07004
HSC000267
Bella Whittle
28. 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.
29. 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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