ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
28 March 2008
Application Code
HSC08003
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”)
Horticulture and Food Research Institute (HortResearch)
To conduct a containment trial with a single ground
application of LBAM sex pheromone mixed with
permethrin, for the purpose of evaluating the efficacy for
the eradication of this species in California and to test this
technology (field trial).
Applicant
Purpose of the Application
Date Application Received
14 March 2008
Consideration Date
28 March 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to import into containment the hazardous substances listed in
paragraph 1.2 is approved with controls as set out in Appendix 1. The approval has
been made in accordance with the legislative criteria set out in Appendix 2.
1.2
The substances have been given the following unique identifiers for the ERMA
New Zealand Hazardous Substances Register:
SPLAT LBAM (HSC08003)
SPLAT adjuvant (HSC08003)
2 Purpose of the application
2.1
The purpose of the application is to seek approval to import experimental quantities
of SPLAT LBAM, which contains the active ingredients E11-tetradecenyl acetate
and E9, E11-tetradecenyl acetate, to trial as pheromone mating disruptors for the
light brown apple moth (Epiphyas postvitanna). In addition, the applicant is seeking
approval to import into containment SPLAT adjuvant, which is of similar
composition to SPLAT LBAM but does not contain the active ingredients.
2.2
The applicant intends to apply a mixture of SPLAT LBAM, SPLAT adjuvant and
Perigen 500 Residual Spray & Insecticide (a HSNO approved insecticide containing
permethrin) using ground based methods at a site located on private land. The site
proposed for the trial is a 10 ha plot of land within Chaney’s Plantation; a pine
forest in Canterbury. The applicant has advised that the area is not inhabited or
used for recreation and does not contain any plants or animals that are used for
human consumption, nor are there any water ways in the area.
2.3
The proposed trials are intended to provide efficiency data to support a response to
the light brown apple moth incursion in the United States. The California
Department of Food and Agriculture (CDFA) has planned treatments of SPLAT
LBAM in California in the northern hemisphere spring, as part of an eradication
programme.
2.4
The applicant notes that the insect is present in New Zealand, and the reversal of
seasons between the northern and southern hemispheres allows for research to be
carried out in New Zealand at a time of year when such trials would not be possible
in the Northern Hemisphere.
3 Application process
3.1
The application was formally received on 14 March 2008.
3.2
Project Team:
3.3
3.4
Elizabeth Morgan
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Faulkner
General Manager, Māori Unit
Noel McCardle
Acting Applications Manager (Hazardous
Substances)
The applicant supplied the following documents:

the application;

a Project Plan; and

confidential appendices including the composition of SPLAT LBAM, safety
data sheets, labels and toxicity studies.
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 Agricultural Compounds and Veterinary Medicines Group;

the Department of Conservation.
3.5
The Department of Conservation responded to the notification and advised that they
did not have any concerns regarding the trial methodology or potential adverse
effects on biodiversity.
3.6
The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)) has indicated to the applicant that pheromone
products are exempt from registration for use over non-food commodities.
3.7
The applicant was provided with a copy of the proposed controls for the pheromone
substances and given the opportunity to comment on them. The comments
provided were taken into account in the setting of controls.
ERMA New Zealand Decision: Application HSC08003
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4 Consideration
Eligibility
4.1
As the purpose (see paragraphs 2.1 and 2.2) amounts to “research and development
on any hazardous substance”, the Project Team considers that the application
qualifies for consideration under section 30(ba).
Lifecycle
4.2
The applicant is seeking approval to import into containment 100 g of SPLAT
LBAM and 2.3 kg of the SPLAT adjuvant, which is of the same composition as
SPLAT LBAM but does not contain the active ingredients E11-tetradecenyl acetate
and E9, E11-tetradecenyl acetate. The applicant intends to trial the substance’s
effectiveness in controlling the light brown apple moth (LBAM) population.
4.3
The applicant intends to import the SPLAT LBAM and SPLAT adjuvant into New
Zealand. Within New Zealand, the substances will be transported by road and air to
the Lincoln premises of HortResearch New Zealand.
4.4
An aerial containment trial (at a different site to that which is proposed in this
application) of a number of LBAM pheromone-based substances, including SPLAT
LBAM, was approved by the Authority earlier this year (refer to application
HSC08001). The pheromones E11-tetradecenyl acetate and E9, E11-tetradecenyl
acetate are a synthetic copy of the natural sex pheromone of the LBAM. The
impact of the substance’s use will be monitored through the trapping of moths in
the experimental area.
4.5
The applicant intends to mix SPLAT LBAM and the SPLAT adjuvant with Perigen
500 Spray & Residual insecticide at the trial site immediately prior to application.
Perigen 500 Spray & Residual insecticide, which is approved under HSNO for use
as an insecticide (approval number HSR000304) contains 500 g/L permethrin and is
intended for use against a range of insect pests in both the domestic and industrial
environments.
4.6
The precise application rates and methods of application are detailed on the product
labels and in the Project Plan. Precautions, first aid advice and advice for spills are
also included on the product labels. Safety Data Sheets (SDS) will be available for
handlers and users of the product to provide further information on safety, disposal
and clean up of spills.
4.7
The labels will clearly specify how much product to mix for each usage, therefore if
the label directions are followed there should be no left over formulation. There
should be no need to dispose of any product in the sales packs as unused product
can be safely stored in its original container until required for a later application. If
there is a need to dispose of product it will be disposed of via an approved waste
contractor.
4.8
Once the three substances are mixed, the applicant intends to apply 5 g dollops of
the mixture to trees in the experimental area. This application method is intended
to provide a two-fold effect: initially, when the rate of pheromone release is
relatively high, the substance will disrupt mating. Once the rate of pheromone
release has decreased, the dollops will act as an attractant; luring the moth to the
dollops, which will then act as an insecticide (due to the permethrin content).
ERMA New Zealand Decision: Application HSC08003
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4.9
The applicant has indicated that, if it is deemed necessary, the dollops can be
scraped off trees at the conclusion of the trial. The Project Team considers that this
should be set as a control.
4.10
The applicant has indicated that empty containers will be triple rinsed and the
rinsate added to the spray tank, and the containers themselves crushed and buried in
a suitable landfill. However, the Project team considers that, as the substances are
not being applied to the ground this means of disposing of the rinsate is not
appropriate. The Project Team considers that all empty containers and equipment
used to apply the substances shall be returned to the applicant for cleaning; and that
the rinsate and empty containers shall then be disposed of in a manner that is
compliant with the Hazardous Substances (Disposal) Regulations 2001.
Hazardous properties
4.11
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 for containment applications, as the substances will be experimental and
may not be commercialised.
4.12
The applicant considers that SPLAT LBAM is likely to trigger the hazard
classifications 6.3B (skin irritant) and 9.1B (ecotoxic in the aquatic environment).
4.13
The Project Team notes that the applicant intends to mix SPLAT LBAM with
Perigen 500 Residual Insecticide & Spray. This substance was approved under
HSNO with the hazard classifications 3.1D (low flammability), 6.1D (oral toxicity),
6.3B (mild skin irritant), 6.4A (eye irritant), 6.5A (respiratory sensitiser), 6.5B (skin
sensitiser), 6.9B (harmful to human organs or systems), 9.1A (very ecotoxic in the
aquatic environment), 9.3B (ecotoxic to terrestrial vertebrates), and 9.4A (very
ecotoxic to terrestrial invertebrates).
4.14
The Project team considers that, as the final mixture of SPLAT LBAM, SPLAT
adjuvant and Perigen 500 Residual Insecticide & Spray is likely to contain only a
low percentage of Perigen 500 it is not likely that all the classifications of this
substance would be conferred to the mixture. However, the hazard profile may be
greater than that which is estimated to be triggered for SPLAT LBAM on its own.
4.15
Overall, the Project Team considers that the information provided by the applicant
is sufficient to determine that any risks posed within the defined lifecycle of the
substances in New Zealand can be managed through the application of controls.
ERMA New Zealand Decision: Application HSC08003
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Identification and evaluation of the significant risks of the substances in
containment
4.16
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, human health and welfare and Māori
issues and concerns as set out below:
Risks to the environment
4.17
The applicant as indicated that, if released into the environment, SPLAT LBAM has
the potential to result in adverse effects within the aquatic environment. The
applicant considers that SPLAT adjuvant will not trigger any hazard thresholds.
The Project Team considers that, should SPLAT adjuvant trigger any hazard
thresholds, the nature and degree of hazard is unlikely to exceed that of SPLAT
LBAM.
4.18
The Project Team considers that, given the hazard profile of Perigen 500 Residual
Insecticide & Spray, exposure to the proposed mixture of SPLAT LBAM, SPLAT
adjuvant and Perigen 500 Residual Spray & Insecticide may cause adverse
environmental effects to terrestrial invertebrates and vertebrates. However, as the
mixture of the three substances will only contain a small proportion of Perigen 500
Residual Insecticide & Spray, the risks are not considered significant provided all
containment controls are adhered to. The Project Team notes that Perigen 500
Residual Insecticide & Spray shall be handled in accordance with HSNO controls
upon which the substance’s approval are conditional.
4.19
Such a release event may also result in adverse effects to terrestrial vertebrates and
invertebrates.
4.20
Given the lifecycles of the substances, adverse environmental effects could arise
from:

an accident during storage, use or transportation, resulting in release of a
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 a substance; or

failure to follow correct disposal procedures.
4.21
The Project Team notes that limited quantities of the substances will be imported
and released into containment for field trials.
4.22
The Project Team notes that, as the substances are applied as dollops which will
later be removed from the trial site, spray drift is not a significant risk.
4.23
In considering the risks to native fauna and flora, the applicant has advised that the
proposed trial area is a pine plantation and as such is relatively poor in native
species. The applicant asserts that, because of the great species specificity of moth
sex pheromones. No effects on any other moth species are expected. The applicant
has discussed the proposed trial with the Department of Conservation (DOC) staff
in Christchurch and has submitted details of these discussions to the Project Team.
DOC staff have indicated to the applicant that they expect there to be little or no
effect on any native invertebrates in the trial area.
ERMA New Zealand Decision: Application HSC08003
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4.24
The Project Team considers that, taking into account the hazardous properties of the
substances, the quantities involved, the containment controls in Appendix 1 and
controls in place under other legislation, there are no significant risks to the
environment from this trial.
Risks to human health and welfare
4.25
The applicant has advised that SPLAT LBAM may be a skin irritant. The Project
Team notes that the applicant considers that SPLAT adjuvant will not trigger any
toxicity hazard thresholds. The Project Team considers that, should SPLAT
adjuvant trigger any hazard thresholds, the nature and degree of hazard is unlikely
to exceed that of SPLAT LBAM.
4.26
The Project Team considers that, given the hazard profile of Perigen 500 Residual
Insecticide & Spray, which is approved for use as an insecticide in New Zealand,
exposure to the proposed mixture of SPLAT LBAM, SPLAT adjuvant and Perigen
500 Residual Spray & Insecticide may cause adverse health effects other than skin
irritation. However, as the mixture of the three substances will only contain a small
proportion of Perigen 500 residual Insecticide & Spray, the risks are not significant
provided all containment controls are adhered to. The Project Team considers that
the risks associated with handling Perigen 500 Residual Insecticide & Spray will be
adequately managed by the HSNO controls upon which the substance’s approval
are conditional.
4.27
Given the lifecycles of the substances outlined, adverse effects could arise from:
4.28

an accident during storage, use or transportation, resulting in release of a
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.
The Project Team considers that there are no significant risks to human health and
welfare, given the properties of the substances, 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
4.29
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.
4.30
The applicant has indicated that SPLAT LBAM is ecotoxic in the aquatic
environment, and is a mild skin irritant. The Project Team notes that the applicant
considers that SPLAT adjuvant will not trigger any hazard thresholds. The Project
Team considers that, should SPLAT adjuvant trigger any hazard thresholds, the
nature and degree of hazard is unlikely to exceed that of SPLAT LBAM.
4.31
Given the hazard profile indicated by the applicant for SPLAT LBAM, there is a
potential that these substances could negatively impact Māori and, or, the mauri of
iwi, cultural tāonga and the environment.
ERMA New Zealand Decision: Application HSC08003
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4.32
Noting the limited size of field trial area, all appropriate controls and conditions
governing the field trial research, and measures to mitigate risks to the mauri of
human health, eco-system integrity and valued taonga species the Project Team
considers the potential for a minimal level of adverse impact occurring on Māori
culture, or, on the traditional relationships with ancestral lands, water, sites, wāhi
tapu, valued flora and fauna or other taonga is highly improbable, and therefore
negligible.
4.33
The Project Team has no evidence to suggest that the controlled use of SPLAT
LBAM and SPLAT adjuvant in containment will breach the principles of the Treaty
of Waitangi and see no requirement for the applicant to further consult with Māori
regarding this application.
4.34
This assessment is made on the condition that the substances are handled, blended,
stored, transported, used and disposed of, in accordance with the explicitly stated
HSNO 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 applicant notify the appropriate
authorities 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
5.2
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.
The Project Team is satisfied that, with adherence to the controls listed in Appendix
1 and those controls in place under other legislation SPLAT LBAM and SPLAT
adjuvant can be adequately contained.
ERMA New Zealand Decision: Application HSC08003
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6 Conclusion
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),
namely research and development on any hazardous substance.
6.2
Having considered the risks associated with the lifecycle of SPLAT LBAM and
SPLAT adjuvant, I am satisfied that the controls imposed, including those in place
under other legislation, will result in the substances being adequately contained.
6.3
The application to import into containment the hazardous substances SPLAT
LBAM and SPLAT adjuvant is thus approved with controls in accordance with
the relevant provisions of the Act and the Methodology as more specifically set out
in Appendix 2.
signed
Rob Forlong
Date: 28 March 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
SPLAT LBAM
SPLAT adjuvant
ERMA New Zealand Decision: Application HSC08003
HSC000328
HSC000327
Page 8 of 13
APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
SPLAT LBAM & SPLAT ADJUVANT
General
1.
The trials shall be undertaken in accordance with the Project Plan 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.
Notwithstanding the requirements of control 1 above, the manufacture and trials shall
also comply with the following controls:
3.
This approval shall expire on 31 December 2008.
4.
This approval applies to the ground based application of a mixture of SPLAT LBAM,
SPLAT adjuvant and Perigen 500 Spray and Residual Insecticide.
5.
This approval excludes application of substances directly into or onto water.
Import
6.
The applicant may import a maximum of:


100 g of SPLAT LBAM
2.3 kg of SPLAT adjuvant
Packaging and Information
7.
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001 and shall be labelled in accordance
with the Hazardous Substances (Identification) Regulations 2001. A safety data sheet
shall accompany each shipment.
Storage
8.
The substances shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004 and the requirements of the Act and the
Resource Management Act 1991.
Transport
9.
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.
ERMA New Zealand Decision: Application HSC08003
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General handling of the substances
10.
Information on appropriate safety precautions necessary to provide safeguards against the
substances’ toxic and ecotoxic properties shall accompany the substances at all stages of
their lifecycles. This shall include information on the appropriate protective clothing that
is to be used and relevant first aid measures for immediate action pending medical
attention.
Trial Site
11.
The trials shall take place in the experimental area of Chaney’s Plantation in Canterbury
as in the Project Plan.
12.
The trial plots shall be chosen so as to prevent the substances entering any surface water
or groundwater system.
13.
Access to the trial sites shall be by permission of the Trial Director1, nominated
researcher or owner of the property on which it is located. The trial site boundaries shall
be clearly marked and distinctly visible from outside the trial site throughout the life of
the trials. The trial sites shall be signed indicating that unauthorised access is not
permitted, that the site is subject to a trial.
Trial Conditions
14.
During use the substances shall be under the control of experimental staff, who are
trained and experienced in the handling and administration of products under test
conditions using the specified equipment. Experimental staff should also be aware of the
study protocol and the controls in place in order to adequately manage the substances.
15.
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.
16.
The amount of substance prepared for application to the trial site shall be the minimum
necessary for the trial, but if there is any surplus mix it shall be returned to HortResearch
for storage or disposal.
17.
The substances shall be applied using equipment calibrated to apply accurate doses to the
nominated trial plots 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 applicant’s trial
records.
18.
A record shall be kept of all use of the substances. 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.
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 Project Plan and approval controls.
ERMA New Zealand Decision: Application HSC08003
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19.
Any equipment used during application shall be returned to HortReseach for cleaning,
and the rinsate and empty containers shall be disposed of appropriately in accordance
with the Hazardous Substances (Disposal) Regulations 2001.
20.
Upon site close off, the Trial Director shall ensure that at the trial site, residue levels for
SPLAT LBAM and SPLAT adjuvant shall be below cut-off levels for toxicological or
ecotoxicological concern, or show that the environmental fate of this component is such
that it is not readily available and will not move off the site. This includes any areas used
for the preparation or disposal of the spray mix.
Emergency Management
21.
Any spillage of the substances (diluted or not) shall be contained, prevented from
entering water bodies, and be absorbed with an appropriate absorbent material. The
absorbent material 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
22.
Any surplus substance remaining at the ‘end of the trials’ shall be returned to
HortResearch where it will be securely stored in a laboratory complying with the
requirements set out in the Hazardous Substances (Exempt Laboratories) Regulations
2001 for the purpose of further analysis or until disposed of. ‘End of trials’ is defined as
the end of the trial programme as defined in the project plan for each substance. (Note
that once the trials are completed the substances will not have approval to be present in
New Zealand except within an exempt laboratory).
23.
Any surplus substances shall ultimately be treated in a manner to render the substance, as
a whole, non-hazardous or be exported from New Zealand. Disposal shall be carried out
in a manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
24.
Containers no longer used to contain the substances and residue or rinsate from
equipment used to handle the substances shall be returned to HortReseach and disposed
of in a manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
25.
The substances, which are to be applied as dollops, shall be collected at the conclusion of
the trial and disposed of in accordance with the Hazardous Substances (Disposal)
Regulations 2001.
Notification and Inspection
26.
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:
ERMA New Zealand Decision: Application HSC08003
Page 11 of 13
Substance name
ERMA Application
number
ERMA Approval numbers
ERMA Applications
Advisor
SPLAT LBAM
SPLAT adjuvant
HSC08003
SPLAT LBAM
SPLAT adjuvant
HSC000328
HSC000327
Elizabeth Morgan
27.
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.
28.
Trial documentation, as described in Control 1, notwithstanding its confidential nature,
shall be available for inspection by any enforcement officer, upon request.
ERMA New Zealand Decision: Application HSC08003
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APPENDIX 2: LEGISLATIVE CRITERIA FOR THE
APPROVAL
A2.1 Unless otherwise stated, references to section numbers in this decision refer to sections of
the Act and references to clauses refer to clauses in the Methodology
A2.2 The application was lodged pursuant to section 31. The decision was made 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 (including the Methodology) and the
provisions of Part III of the Third Schedule of the Act.
A2.3 Government departments with an interest in this type of application were advised of the
receipt of the application in accordance with clause 2(2)(e).
A2.4 This application was considered by the Chief Executive of ERMA New Zealand under
delegation from the Authority (section 19(2)(e)).
A2.5 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 (Clauses 9, 12, 13, 14, 22, 24, 25) 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.
A2.6 In accordance with clause 36(2)(b), it is recorded that, in reaching his decision, the Chief
Executive applied the criteria specified in section 32.
A2.7 The Chief Executive also applied the following criteria in the Methodology:

clause 11 – characteristics of substance;

clause 21 – the decision accords with the requirements of the Act and
regulations;

clause 26 – all risks negligible;

clause 35 – the costs and benefits of the controls.
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