Amended under s67A 9 May 2008
ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
14 February 2008
Application Code
HSC07044
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”)
Animal Health Board
Applicant
Purpose of the Application
To monitor the effects on non-target species of the aerial
application of GEDR 1080 pellets (field trial)
Date Application Received
10 December 2007
Consideration Date
14 February 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to field trial Green Epro Deer Repellent (GEDR) on 0.15% 1080
Pellets at Mount Stalker and Beaumont Forest 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 substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
GEDR on 0.15% 1080 Pellets (HSC07044)
2 Purpose of the application
2.1
The purpose of the application is to allow the manufacture of GEDR on 0.15%
1080 Pellets and the conduct of trials to determine whether the risk profile of the
bait is changed in respect of endangering non-target species.
2.2
The proposed trials are to monitor effects of GEDR on 0.15% 1080 Pellets on
tomtits and robins to provide data to support an application to ERMA New Zealand
for release of the substance in New Zealand. The effects of the bait on the deer
population will also be monitored.
3 Application process
3.1
The application was formally received on 10 December 2007.
3.2
Project Team:
Noel McCardle
Senior Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Faulkner
General Manager, Māori Unit
Beth Dye
Applications Manager (Hazardous Substances).
3.3
The applicant supplied the following documents:
 the application;
 a progress report on the monitoring at Rotoaira (under Approval HSC000287);
 a bird monitoring proposal; and
 a deer monitoring proposal.
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 New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group));
 The Department of Conservation (DoC).
3.5
DoC commented as follows:
 There are no robins in the Mount Stalker area – only tomtits.
 The design of this trial without the inclusion of a [non-GEDR] 1080 bait
treatment appears to be somewhat deficient.
3.6
In response to DoC’s comments, the applicant advised as follows:
 The applicant proposes to monitor both tomtits and robins (if available) as they
are the two standard indicator species. A scoping trip will determine what
species are present and if tomtits only are present then data will only be
collected on them. Similarly, there were not enough robins at Rotoaira for a
robust comparison, although data were collected on what was there anyway.
 That researchers were intending to compare the deer repellent 1080 bait results
with the aerial control using standard 1080 baits when the same area was done
in 2001. This is being done as to include a standard 1080 bait trial would require
that a section of the operation be set aside for using this bait. This would
involve getting the deer hunters to accept application of standard 1080 and a
consequent increase in the cost of the research. The applicant considers that the
difference in results between the two treatments (standard 1080 in 2001 and
deer repellent 1080 in 2008) will be such that the only explanation will be the
use of deer repellent in 2008.
3.7
While DoC considers that the trial design could be better in terms of assessing the
non-target effects of GEDR for product registration, they advised that they can
accept a GEDR vs. a non-treatment area comparison.
ERMA New Zealand Decision: Application HSC07044
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3.8
The applicant was provided with a copy of the proposed controls for the trials and
given the opportunity to comment on them. The comments provided were taken
into account in the setting of controls.
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
Animal Control Products Limited will manufacture the uncoated pellets. The pellets
will be transported from Wanganui to Epro Ltd by commercial truck transport in
accordance with the relevant HSNO regulations and the Land Transport Rule –
Dangerous Goods.
4.3
The pellet baits will be coated with GEDR using a rotating auger. GEDR is a deer
repellent formulation supplied by Epro Ltd. The pellet baits will then be forwarded
to Otago.
4.4
Prefeeding of the trial area using non-toxic cereal bait, applied by helicopter with an
under slung bucket at a rate of 2 kg/ha, will occur prior to application of the toxic
bait.
4.5
Application of the toxic bait is expected to occur within 2 weeks of prefeeding,
weather dependent. Application rate is 2 kg/ha, by helicopter with under slung
bucket.
4.6
Bait will be broadcast from a helicopter fitted with high precision navigational
guidance equipment (GPS). The helicopter loading site is inside the containment
area, and with the use of the GPS guidance system there is a very low risk of any
bait being inadvertently applied outside the designated trial area. The boundaries of
the trial area will be uploaded to the helicopter’s onboard navigational system prior
to application, and the pilot will also fly a pre-operational visual inspection of the
boundaries with the operational controller.
4.7
The Mt Stalker operation will involve aerial application to 5928 hectares of land,
4925 hectares of which is administered by DoC.
4.8
The Beaumont Forest operation will involve 6751 hectares to be aerially treated.
This land is mixed native bush and exotic tree plantings. The bush is DoC
administered land and the exotic is owned by Ngai Tahu and leased to Ernslaw One
Forestry.
4.9
The bait will degrade in situ at a rate dependent primarily on rainfall. As the trial
area is a high rainfall area, it is expected the baits will be effectively non-toxic
within 2 months after application.
ERMA New Zealand Decision: Application HSC07044
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4.10
Unused bait will be transported by truck (or utility vehicle) back to the poison store
at the local depot, for subsequent routine disposal by incineration.
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.
4.12
The project team notes that 0.15% 1080 cereal pellets are covered by the approval
Cereal based pellets containing 1.5 - 2.0 g sodium fluoroacetate/kg (HSNO
Approval Code: HSR002424).
4.13
These pellets were included in the reassessment of substances containing 1080 and
as part of the reassessment were classified as follows:
 6.1B acute oral toxicant;
 6.1C acute inhalational toxicant;
 6.8A known reproductive toxicant;
 9.1D slightly harmful to aquatic life;
 9.3A highly toxic to terrestrial vertebrates.
4.14
The data provided by Epro Ltd. show that GEDR is non-hazardous.
4.15
The Project Team is satisfied that the GEDR on 0.15% 1080 Pellets combination of
the pellet baits and GEDR, will pose similar hazards to human health and the
environment as are posed by the pellet baits.
4.16
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
substance in New Zealand can be managed through the application of controls.
Identification and evaluation of the significant risks of the substances in
containment
4.1
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Project Team
considered the potential risks of escape from containment under the headings of
environmental, human health and welfare and Māori issues and concerns.
4.2
The following risk assessment takes into account the application of the controls that
apply to 0.15% 1080 cereal pellet bait as a result of the reassessment of substances
containing 1080; the proposed containment controls; and controls in place under
other legislation, such as the Resource Management Act 1991.
4.3
The Project Team also took into account the risk assessment made by the Authority
in considering the use of the same pellets in trials in Lake Rotoaira Forest and
Turangi (see application number HSC07024).
ERMA New Zealand Decision: Application HSC07044
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Risks to the environment
4.4
The Project Team considers that, taking into account the controls that apply to the
1080 cereal baits, the containment controls listed in Appendix 1, the containment
measures proposed by the applicant and controls in place under other legislation,
the only potential environmental risks relate to exposure of non-target species at the
trial site. These species include livestock who may feed on bait, dogs (through
direct ingestion of bait or through secondary poisoning) and indigenous fauna
(including birds).
4.5
The risks to livestock and dogs are managed by the consent conditions and standard
HSNO controls on the use of substances containing 1080 and are not considered
any further for the purposes of this application.
4.6
The risks to native non-target species from the GEDR coated bait are uncertain,
hence the need to conduct the field trials. The applicant has provided a number of
references which suggest that the risks to tomtits and robins are no greater than for
non-GEDR treated cereal pellets; however, adequate monitoring has not been
conducted on the scale proposed in this application.
4.7
Details of the proposed bird monitoring are included in Appendix 2 of the
application. The Agency notes that while the initial proposal was to monitor both
robins and tomtits as the birds most vulnerable to 1080 pellets, DoC has advised
that there are no robins present on the GEDR treatment sites. Therefore, the
monitoring will focus on tomtits. Non-treatment sites will also be monitored to
provide for comparison of results across treatments.
4.8
While there is some residual risk to non-target species, and small passerine birds in
particular from exposure to the GEDR treated pellets, given the scale of the trials
and the ability of populations of these birds to recover relatively quickly from an
impact, the Project Team considers that the benefits to be gained from the trial, ie
robust monitoring data, outweigh the risks.
Risks to human health and welfare
4.9
The Project Team considers that, taking into account the controls that apply to the
1080 cereal baits, the containment controls listed in Appendix 1, the containment
measures proposed by the applicant and controls in place under other legislation,
there are no significant risks to human health and welfare.
Relationship of Māori to the Environment
4.10
The Project Team notes that the applicant has consulted with the appropriate
iwi/Māori organisations and interest groups about the containment proposal
receiving support from Te Runanga o Otakou and Te Runanga o Moeraki. None of
the 9 organisations contacted raised any issues of concern.
4.11
Although there is some uncertainty relating to risks to native non-target species
from the GEDR coating (as outlined in paragraphs 4.6 – 4.8) and therefore to the
mauri of those species and ecosystems, the Project Team considers that the role of
ERMA New Zealand Decision: Application HSC07044
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iwi/Māori as kaitiaki has been preserved by their ongoing involvement in
operations of this kind.
4.12
In addition the Project Team notes that the comprehensive monitoring regime
proposed will provide information of significant benefit to iwi/Māori generally
about the effects posed by the substance should it be the subject of a future release
(see control 16).
4.13
The Project Team considers that release beyond the contained areas is adequately
managed by the nature of this ongoing dialogue with interested parties and the
standard and suggested controls proposed for the trial will mitigate the risk of
unintended release to negligible levels.
4.14
From the information provided, and considering that the application is for field
trials, the Project Team considers that GEDR coated bait 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.
4.15
However, should inappropriate or accidental use, transport or disposal of the
substance result in the contamination of waterways and or land outside the
containment areas, it is suggested that the applicant notify the appropriate iwi land
owner and or other 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.
5.2
The Project team is satisfied that, with adherence to the controls listed in Appendix
1, including controls that apply to the 1080 cereal baits, the containment measures
proposed by the applicant and those controls in place under other legislation, GEDR
on 0.15% 1080 Pellets can be adequately contained.
ERMA New Zealand Decision: Application HSC07044
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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 GEDR on 0.15% 1080
Pellets, I am satisfied that the controls imposed, including those in place under
other legislation, will result in the substance being adequately contained.
6.3
The application to manufacture in containment the hazardous substances GEDR on
0.15% 1080 Pellets 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: 14 February 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
GEDR on 0.15% 1080 Pellets
(HSC07044)
ERMA New Zealand Decision: Application HSC07044
HSC000315
Page 7 of 11
Amendment May 2008
In Appendix 1 of the original decision, control 18 read as follows:
A maximum amount of 10.5 tonnes of GEDR on 0.15% 1080 Pellets shall be applied to
5928 hectares of treatment area in Mt Stalker and 14 tonnes shall be applied to 6751
hectares of treatment area in Beaumont Forest.
The maximum amount of GEDR on 0.15% 1080 Pellets has increased from 10.5 tonnes to
12 tonnes under section 67A of the Hazardous Substances and New Organisms Act 1996.
Control 18 now reads as follows:
A maximum amount of 12 tonnes of GEDR on 0.15% 1080 Pellets shall be applied to
5928 hectares of treatment area in Mt Stalker and 14 tonnes shall be applied to 6751
hectares of treatment area in Beaumont Forest.
Rob Forlong
Chief Executive
ERMA New Zealand
ERMA New Zealand Decision: Application HSC07044
Date:
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCES, GEDR on 0.15%
1080 Pellets (HSC07044)
1. The manufacture of GEDR on 0.15% 1080 Pellets and the associated field trials shall be
undertaken in accordance with the application. Modifications of the arrangements may be
approved in writing by ERMA New Zealand providing that they comply with the
following controls.
2. The controls that apply to Cereal based pellets containing 1.5 - 2.0 g sodium
fluoroacetate/kg (HSNO Approval Code: HSR002424) under the Act apply to GEDR on
0.15% 1080 Pellets.
3. Notwithstanding the requirements of controls 1 and 2 above, the trials shall also comply
with the following controls:
4. Access to the manufacturing facility shall be limited to authorised persons only.
5. The trials shall only be carried out at the locations identified by the applicant in the
application as the field trial sites.
6. During storage, GEDR on 0.15% 1080 Pellets shall be kept in a locked storeroom at the
premises.
7. The substance shall be transported in accordance with the Land Transport Rule
(Dangerous Goods 2005) where applicable. A safety data sheet shall be kept with the
substance during transport.
8. Any spillage of the substance during manufacture, transport (other than transport by
helicopter) and storage shall be recovered and placed in bins, bags or buckets and
returned to the manufacturer for disposal.
9. GEDR on 0.15% 1080 Pellets baits shall be dyed green.
10. Persons handling GEDR on 0.15% 1080 Pellets at any stage of its lifecycle, including
cleaning up any spilt substance for disposal, shall wear suitable personal protective
clothing.
11. The Department of Labour, [Attn. HSNO Project Manager (Workplace Group) P O Box
3705, Wellington], and ERMA New Zealand shall be informed in writing (by letter, fax
or email) of the location, start, and completion of the trials. This notification shall be
done at least 1 week, but not more than 2 months, before the start of the trial.
Notifications shall include the following details:
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
ERMA New Zealand Decision: Application HSC07044
GEDR on 0.15% 1080 Pellets
HSC07044
HSC000315
Noel McCardle
Page 9 of 11
12. 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.
13. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
14. Bird monitoring shall be conducted as set out in section 2.2 of the application within the
areas indicated on the map provided with the application.
15. A full monitoring report shall be provided to ERMA New Zealand on completion of the
trials.
16. A full monitoring report shall be provided to the 9 iwi/Māori organisations consulted in
relation to this application (namely Te Runanga o Moeraki, Kati Huirapa Runaka ki
Puketeraki, Te Runanga o Otakou, Hokonui Runanga Inc. Society, Waihopai Runaka Inc,
Awarua Runanga, Moturata Taieri Whanau, South Otago Ngai Tahu Runanga Inc. and Te
Ao Marama Incorporated) on completion of the trials.
17. This approval remains in place until 31 December 2008.
18. A maximum amount of 12 tonnes of GEDR on 0.15% 1080 Pellets shall be applied to
5928 hectares of treatment area in Mt Stalker and 14 tonnes shall be applied to 6751
hectares of treatment area in Beaumont Forest.
ERMA New Zealand Decision: Application HSC07044
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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.
ERMA New Zealand Decision: Application HSC07044
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