ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
13 December 2006
Application Code
HSC06028
Application Type
To import a hazardous substance into containment under
Section 31 of the Hazardous Substances and New Organisms
Act 1996 (the Act)
Applicant
Bayer NZ
3 Argus Place
Glenfield
Auckland
Purpose of the Application
Merit 200 SL: To import into containment and assess the
efficacy of a 20% SL imidacloprid formulation to be
administered as an injection for the control of various insect
pests in Eucalyptus, Lophostemon and Pinus tree species.
Date Application Received
17 October 2006
Consideration Date
13 December 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of decision
1.1
The application to manufacture in containment the hazardous substance, Merit 200
SL, has been 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:
Merit 200 SL
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 as 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
3
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.
Application process
3.1
The application was formally received on 17 October 2006.
3.2
Project Team:
Bella Whittle
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Robinson
General Manager (Māori Unit)
3.3
The applicant supplied the following documents:
 the application; and
 confidential appendices, including supporting studies, copies of material safety data
sheets, and compositional details.
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); and
 the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the New
Zealand Food Safety Authority (NZFSA).
3.5
The applicant was provided with a copy of the proposed controls for Merit 200 SL and
given the opportunity to comment on them.
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 HSC06028
Page 2 of 11
Purpose of the application
4.3
The application has been submitted to cover the importation of 50 L of the substance,
Merit 200 SL, into containment for the purpose of conducting field trials to assess its
efficacy against sap sucking insects in Pinus Radiate. spp., and gum leaf skeletoniser
(Uraba lugens) in Eucalyptus spp. and Lophostemon spp. The substance will be
administered to trees by direct injection, under trial conditions, to determine the
substance’s safety.
4.4
The Project Team considers that the purpose of the application, as stated, amounts to
“research and development on any hazardous substance” and therefore qualifies for
consideration under section 30(ba).
Life cycle
4.5
The applicant advises that Merit 200 SL will be manufactured in Australia and shipped
to New Zealand in 1 L HDPE plastic drums. The containers will be labelled with the
necessary safety, first aid, storage and disposal information.
4.6
The applicant advises that the product will be transported to the trial sites by licensed
carriers compliant with land transport regulations. The responsibility of conducting the
trials will be limited to one organisation only and, as a result, extensive use of land
transport will not be required. Any storage required prior to product being used in the
trials will be in warehouses specifically designed for the purpose of chemical storage.
The applicant advises that following storage recommendation will appear on the label:
“Store in tightly closed, original container in a safe, well ventilated area, as cool as possible away from
foodstuffs. Do not store for prolonged periods in direct sunlight.”
1
4.7
Merit 200 SL will be used by direct injection. For the purposes of this trial, tree
injection equipment manufactured by Sidewinder will be used. There are a number of
variations, but the basic equipment design uses a 12 volt electric drill and compressed
air operated pump. The equipment and a bottle of product are carried on a backpack.
4.8
To treat each tree, a hole is drilled square on to the tree surface in one continuous
motion using a standard drill bit (6 mm diameter x 40 mm long). The nozzle is screwed
into tree's active xylem and the dosing pump is activated. When the pressure has
dropped or the manual pump handle is right down, the drill is reversed and the nozzle
unscrewed. Approximately 50 mL of product will be injected per tree.
4.9
A plastic sealing plug is then screwed into tree, leaving approximately 6 mm
protruding. Plugs will be totally over grown within 12 to 18 months depending on the
species and vigour of tree.
4.10
For the purposes of trialling Merit 200 SL, the users of this product will be confined to
forestry professionals within the Ensis1 organisation.
Ensis is an unincorporated joint venture between Australia’s CSIRO and New Zealand’s Scion
ERMA New Zealand Decision: Application HSC06028
Page 3 of 11
4.11
As the product is injected directly into the tree, the applicant considers that there will
be no formation of waste products, by-products or metabolites. Any remaining
product will be disposed of according to label directions.
4.12
Disposal instructions on the label of Merit 200 SL will specify the disposal methods
for both the product and used container.
4.13
The use pattern of Merit 200 SL is such that the product will be stored in the original
container and used as necessary until the container is empty. The need to dispose of
large quantities of undiluted product is considered to be unlikely. The applicant advises
that, in accordance with the Hazardous Substances (Disposal) Regulations 2001, the
following statement regarding product disposal will be present:
“Dispose of this product only by using according to the label, or at an approved landfill, or other
approved facility.”
4.14
The applicant also advises that, in accordance with the Hazardous Substances
(Disposal) Regulations 2001, the following statement regarding used container disposal
will be present on the label:
“Ensure container is completely empty. Burn in an appropriate incinerator if circumstances, such as
wind direction, permit. Otherwise crush or puncture and bury in a suitable landfill, or if appropriate,
recycle. Do not use container for any other purpose.”
4.15
Product remaining at the end of the trial will either be returned to Bayer New Zealand
or disposed of according to the Hazardous Substances (Disposal) Regulations, as
described on the product label and accompanying Safety Data Sheet.
Hazardous properties
4.16
The Project Team notes that containment applications only require a sufficient
understanding of a substance’s hazardous properties to ensure that any risks posed can
be managed by controls set under the containment provisions.
4.17
The applicant has provided some information about the hazardous nature of the
substance, Merit 200 SL.
4.18
With regard to ecotoxicity, the applicant notes that the substance is very toxic to
terrestrial invertebrates. In addition, the Project Team considers Merit 200 SL to be
highly ecotoxic in the aquatic environment, and ecotoxic in the soil environment.
4.19
With regard to toxicity, the applicant considers the substance to trigger the acute
toxicity threshold (via the oral and dermal routes). The Project Team also notes that
the substance is a target organ systemic toxicant.
4.20
The Project Team has reviewed the summary data and other information supplied by
the applicant and considers that the information is sufficient to determine that any
risks posed within the defined lifecycle of the substance in New Zealand can be
managed through the application of controls as defined in Appendix 1.
ERMA New Zealand Decision: Application HSC06028
Page 4 of 11
Identification and evaluation of the significant risks of the substance in
containment
4.21
The applicant has identified and assessed the potential risks and impacts that may arise
from the substance’s contained presence and use in New Zealand. The applicant has
also detailed measures to manage those identified risks and impacts. The Project Team
has reviewed the applicant’s assessment of potential risks and impacts with regard to
the environment, human health and welfare, and Maori issues and concerns. The
Project Team’s review of potentially significant risks is summarised below.
Risks to the environment
4.22
If released into the environment the substance has the potential to result in adverse
effects within the environment.
4.23
On the basis of the lifecycle of the substance, adverse environmental effects could
arise from:
 an accident during importation, transportation or storage, resulting in release of the
substance into the environment;
 failure to maintain or properly use application equipment;
 failure to follow correct disposal procedures as outlined in the containment plan;
 failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance;
 run-off of the substance from treated trees entering the environment; or
 potential exposure of bees and other invertebrates via pollen and nectar of treated
trees.
4.24
The applicant states that, since the product is injected directly into trees, and an
effective injection site sealing method is in place, the risk of chemical escape is
minimal. The applicant considers that beneficial insects, mammals and birds are
generally unaffected by internal tree application of pesticides, as only insects
consuming plant tissue or fluids are at risk.
4.25
However, the Project Team notes that the substance will be present within the pollen
and nectar of the treated trees. This may pose a risk to non-target invertebrates, such
as bees. The Project Team has proposed specific controls to manage the risk to bees
for the duration of the trials. Specifically, it is proposed that Merit 200 SL shall not be
applied trees that are in flower or used within a period 3 months prior to flowering of
any treated tree.
4.26
The Project Team considers that the contained import and trialling of Merit 200 SL
will not pose any significant risks to the environment. In its consideration, the Project
Team took several factors into account, including the containment regime proposed by
the applicant, the overall quantity of the substance involved, the controls set out in
Appendix 1 and the requirements of other legislation.
Risks to human health and welfare
4.27
Given the level of detail and related uncertainty involved in studies conducted for the
experimental substances such as Merit 200 SL, the Project Team considers that adverse
effects to human health and welfare may result from exposure(s) to the substance.
ERMA New Zealand Decision: Application HSC06028
Page 5 of 11
4.28
On the basis of the substance’s lifecycle, exposure resulting in adverse effects could
arise from:
 an accident during importation, transportation, storage or use, that results in release
of the substance;
 public exposure to the substance from contact with treated trees;
 failure to follow correct disposal procedures as outlined in the containment plan; or
 failure to follow the correct operational procedures as set out in the controls,
resulting in release the substance.
4.29
The applicant notes that only 50 mL of product is injected per tree, so the risk of
contact by the general public, operators and other workers is reduced in comparison
with pesticides that are applied in large volumes by surface application and pose the
risk of spray drift.
4.30
With regard to public exposure, the Project Team has considered the duration of the
trials and use pattern. Trees are to be treated once only, by direct injection. Thus, it is
considered highly improbable that a member of the public would be exposed to a
sufficient quantity to cause an acute adverse health effect; or for a sufficient duration
to cause a chronic effect. In addition, treated trees are to be marked so as to
distinguish them from untreated trees.
4.31
Taking into consideration factors, such as, the substance’s limited availability, its
handling by trained staff and use of personal protective equipment (PPE) the Project
Team considers it unlikely that the contained import and trialling of Merit 200 SL
would result in adverse effects to human health and welfare. If any effects were to
occur it is envisioned that they would most likely be relatively minimal in nature and
would be limited to persons directly involved in the trials.
Māori issues and concerns
4.32
The potential Māori cultural effects were considered 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 Protocol “Incorporating Māori
Perspectives in HSNO Decision Making” to assess this application.
4.33
Merit 200 SL has hazardous properties that trigger HSNO toxicity and ecotoxicity
thresholds. These hazardous properties give rise to the potential for cultural risk
including the deterioration of the mauri of taonga flora and fauna species (particularly
invertebrate taonga species), the environment and the general health and well-being of
individuals and the community. In addition, the introduction and use of this substance
has the potential to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki,
particularly in relation to the guardianship of waterways.
4.34
After careful consideration of the risks associated with this substance, its limited
intended use in this trial and the containment regime proposed, the Project Team
considers any adverse effect occurring with regard to Māori culture or traditional
relationships with their ancestral lands, water, sites, wāhi tapu, valued flora and fauna
or other taonga to be negligible. This assessment is made on the condition that Merit
200 SL is handled, stored, transported, used, and disposed of, in accordance with the
explicitly stated HSNO controls, and any controls stipulated in other applicable Acts.
ERMA New Zealand Decision: Application HSC06028
Page 6 of 11
4.35
In addition the Project team has no evidence to suggest that the controlled and
contained use of Merit 200 SL will breach the principles of the Treaty of Waitangi and
see no requirement for the applicant to consult with Māori regarding this application.
4.36
However, should inappropriate use, or an accident, result in the contamination of the
environment, it is suggested that Bayer NZ or Ensis 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 (for example, control 4);
 to exclude organisms from a facility (for example, control 16);
 to exclude unauthorized people from the facility (for example, control 18);
 to prevent unintended release of the substances by experimenters working with the
substance (for example, control 15);
 to control the effects of any accidental release of the substance (for example,
control 20);
 inspection and monitoring requirements (for example, control 23); and
 qualifications required of the person responsible for implementing the controls (for
example, control 13).
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, Merit 200 SL, can be adequately contained.
6
DECISION
6.1
I have considered this application made under section 31, pursuant to section 32, and
am satisfied that this application is for the purpose specified in section 30(ba) i.e. for
purposes of the “research and development” on Merit 200 SL.
6.2
Having considered the risks associated with the lifecycle of the substance, I am
satisfied that the controls imposed in Appendix 1 and those in place under other
legislation, will result in the substance 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 substances;
 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 HSC06028
Page 7 of 11
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
6.5
The application to import into containment the hazardous substance, Merit 200 SL, is
thus approved pursuant to section 32, with the controls set out in Appendix 1.
Rob Forlong
Date 13 December 2006
Chief Executive of ERMA New Zealand
Merit 200 SL
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC06028
HSC000256
Page 8 of 11
APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCE, MERIT 200 SL
General
1. All lifecycle stages from import to disposal shall be undertaken in accordance with the
information provided by the applicant with their application. A trial protocol shall be
submitted to ERMA New Zealand in advance of any trial work. The trial protocol is to be
consistent with the controls and trial conditions specified within this decision. Modification
of the information provided in the application or trial protocol may be approved in writing
by ERMA New Zealand provided that those modifications comply with the following
controls.
2. Notwithstanding the requirements of control 1 above, the importation and trials shall also
comply with the following controls:
Import
3. Bayer NZ Ltd may import approximately 50 L of the substance, Merit 200 SL, into
containment in New Zealand.
Packaging and information
4. The substance 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 Bayer NZ Ltd.
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 substance shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004.
Transport
8. 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
9. Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substances, for example during handling,
application and disposal.
ERMA New Zealand Decision: Application HSC06028
Page 9 of 11
Trial conditions
10. This approval applies to the administration of the substance, Merit 200 SL, using specialised
equipment to administer the substance.
11. The trials may be carried out at a location that is not defined until an infestation of the target
pest has been found, provided the applicant:
- has permission from the owner of the land to carry out the trial;
- notifies ERMA New Zealand of the location as per control 23.
12. The trials shall be limited to 50 trees per species (Pinus radiata spp., Eucalyptus spp. and
Lophostemon spp.). Each tree shall be treated once only.
13. During use the substance shall be under the control of experimental staff, who are trained
and experienced in the handling and administration of insecticides 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.
14. The substance 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. The substance shall be applied by injection to Pinus radiata spp., Eucalyptus spp. and
Lophostemon spp. After use, the equipment used for application shall be disposed of in an
appropriate manner or be cleaned with the residue and/or rinsate being treated in manner so
that it is no longer hazardous.
16. Merit 200 SL shall not be applied to treat trees that are in flower or applied within a period 3
months prior to flowering of any treated tree.
17. The trials shall be conducted in such a way as to prevent the substance entering any surface
water or groundwater system.
18. Treated trees shall be marked in a manner such that they may be clearly identified and
distinguished from untreated trees.
19. 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.
Emergency management
20. Any accidental spillage of the substance shall be contained, prevented from entering
waterways, and absorbed with an appropriate absorbent material. This 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.
Disposal
21. Any surplus substance remaining at the end of the trials shall be returned to Bayer NZ Ltd
where it will be securely stored (in an exempt laboratory), until needed for further analysis, or
ERMA New Zealand Decision: Application HSC06028
Page 10 of 11
be disposed of in a manner compliant with the Hazardous Substances (Disposal) Regulations
2001. Please note that once the trials are completed the substance does not have approval to
be present in New Zealand except in an exempt laboratory.
22. Containers no longer used to contain the substance or residue or rinsate from equipment
used to handle the substance shall be disposed of in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001.
Notification and inspection
23. 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
Merit 200 SL
HSC06028
HSC000256
Bella Whittle
24. 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.
25. 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.
26. 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.
ERMA New Zealand Decision: Application HSC06028
Page 11 of 11