ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

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ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
12 September 2007
Application Code
HSC07024
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous
Substances and New Organisms Act 1996
Applicant
Animal Health Board
Purpose of the Application
To field trial by aerial distribution, Green Epro Deer
Repellent (GEDR) on 1080 Cereal Bait, to determine
whether the risk profile of the cereal bait is changed in
respect of endangering non-target species
Date Application Received
10 September 2007
Consideration Date
11 September 2007
Considered by
A Committee of the Authority (“the Committee”)
1 Summary of Decision
1.1
The application to field trial by aerial distribution, Green Epro Deer Repellent
(GEDR) on 1080 Cereal Bait, is approved with controls in accordance with the
relevant provisions of the Hazardous Substances and New Organisms Act 1996 (“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:
GEDR on 0.15% 1080 Pellets
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 relevant to the purpose of the Act, 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
Consideration of the application followed the relevant provisions of the Methodology.
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3 Application Process
3.1
The application was formally received on 10 September 2007.
3.2
Project Team:
Noel McCardle
Senior Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Faulkner
General Manager, Māori.
Report review and sign-out by:
Dr Peter Dawson
Principal Scientist (Hazardous Substances).
3.3
The applicant supplied the following documents:
 The application;
 Research Reports;
 Assessments of Environmental Effects (AEEs);
 Bird Monitoring Maps.
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 Conservation
 the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.4.1
3.5
The Department of Conservation commented that Fantails and Tomtits are
absolutely protected species under the Wildlife Act 1953. However, there are
no issues with this as this is an observational study with no manipulation or
invasiveness using standard pest control techniques (apart from the deer
repellent), and the trial has high conservation relevance which should be
supported.
The applicant was provided with a copy of the proposed controls for GEDR on
0.15% 1080 Pellets and given the opportunity to comment on them. The comments
received from the applicant were taken into account when considering this application.
4 Consideration
Sequence of the Consideration
4.1
The following members of the Authority’s Hearings Committee considered the
application in accordance with a delegation under section 19(2)(b)): Mr Neil Walter
(Chair), Professor George Clark, Dr Manuka Henare and Ms Helen Atkins.
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 associated with the application and to
ERMA New Zealand Decision: Application HSC07024
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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.
Purpose of the Application
4.3
As GEDR on 0.15% 1080 Pellets is a new hazardous substance within the meaning of
the Act, it will require an approval under the Act before it can be released. The
purpose of this containment application is to allow the manufacture of the new
formulation in containment and the conduct of trials to determine whether the risk
profile of the cereal bait is changed in respect of endangering non-target species.
4.4
The Committee notes that such research on any hazardous substance to acquire
information for use in assessing that substance in accordance with the Act qualifies for
consideration under section 30(b).
Lifecycle
4.5
Animal Control Products Limited will manufacture the uncoated pellets. The pellets
will be transported from Wanganui to Epro Taupo by commercial truck transport in
accordance with the relevant HSNO regulations and the Land Transport Rule –
Dangerous Goods.
4.6
The pellet baits will be coated with GEDR using a rotating auger. GEDR is a deer
repellent formulation supplied by Epro Ltd. GEDR will be sprayed into the pellets as
they travel up the elevating auger. Movement of the pellets as they travel up the auger
will be sufficient to completely coat each pellet.
4.7
The baits will then be air dried before being bagged in helicopter loads. The flexible
large packaging used to hold treated pellets is approved as large packaging as required
under Part 2A of the Hazardous Substances (Packaging) Regulations 2001. These bags
will be loaded on to trucks at the Epro Depot on the day of the operation before being
transported to the helicopter loading sites located inside the treatment area. The bags
are tied closed at the top to prevent accidental spillage.
4.8
Prefeeding of the trial area using non-toxic cereal bait, applied by helicopter with an
under slung bucket at a rate of 2kg/ha will occur prior to application of the toxic bait.
4.9
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.
4.10
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 in 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.
4.11
Approximately 18 tonnes of GEDR 1080 pellets will be applied to 9000 hectares of
treatment area. The GEDR trial sites are smaller blocks within a much larger aerial
1080 Tb vector control operation which has been in progress since early July 2007.
ERMA New Zealand Decision: Application HSC07024
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These sites are as marked on the map provided in the application. The larger
operation in its entirety has been granted the necessary resource consent from
Environment Waikato and permissions as required from the Medical Officer of Health
and the Department of Conservation.
4.12
The GEDR trial sites are located on Lake Rotoaira Forest Trust land, which
incorporates a mix of mature pine/cypress with manuka shrubland, mature and
regenerating beech/hardwood forest.
4.13
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.
4.14
Unused bait will be transported by truck (or utility vehicle) back to the poison store at
the Epro Depot at Taupo, for subsequent routine disposal by incineration.
4.15
Large packaging is returned to the Epro Depot and reused. The multi-wall paper bags
used to hold the pellets before treatment with GEDR and any small amounts of
unused bait on completion of the operation will be burned in an industrial incinerator
at the Epro Depot at Taupo.
Hazardous Properties
4.16
The 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).
4.17
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.
4.18
The data provided by EPRO Ltd. show that GEDR is non-hazardous.
4.19
The Committee 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.
Identification and evaluation of the significant risks of the substance in
containment
4.20
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Committee
considered the potential risks of escape from containment under the headings of
environmental, human health and welfare and Māori issues and concerns.
4.21
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
ERMA New Zealand Decision: Application HSC07024
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containing 1080; the proposed containment controls; and controls in place under other
legislation, such as the Resource Management Act 1991.
4.22
In this regard, the Committee notes that all necessary consultation has been
undertaken with the owners of the trial sites and adjacent landowners, along with other
interested parties associated with the whole operation. This information is documented
as Appendix 2 of the AEE for Lake Rotoaira Forest and Appendix 3 for the AEE for
Turangi Sector 5A.
Risks to the Environment
4.23
The Committee 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).
4.24
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.
4.25
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.
4.26
Details of the proposed bird monitoring are included in the application on pages 3-5.
The Agency notes that while the initial proposal was to monitor both robins and
tomtits as the birds most vulnerable to 1080 pellets, a recent site inspection by the
contractor undertaking the monitoring indicates that there are probably insufficient
numbers of robins present on the GEDR treatment sites. Therefore, the monitoring
will focus on tomtits. Non-treatment sites and areas treated with standard 0.15% 1080
cereal sites will also be monitored to provide for comparison of results across
treatments. The Agency envisages that further field trials may be required to extend
the range of habitat types and number of species being monitored.
4.27
Table 1 shows a summary of the work to date on Epro Deer Repellent (EDR) and
GEDR deer repellents. It is noted that EDR has been used on carrot bait and has
previously been trialed without HSNO approval on cereal bait (e.g. Lorigan 2006;
Morriss et al 2006). The EDR turned the cereal pellets brown rather than green as
required by the controls on substances containing 1080. Therefore, GEDR was
developed and when it is applied to cereal pellets the bait remains green.
ERMA New Zealand Decision: Application HSC07024
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Table 1 Summary information: trials on effects of EDR and GEDR deer repellents in target
and non-target species
Species being
monitored and location
of trials
Bait type and
application rate
Summary of results
Reference as
listed in
bibliography to
the application
North Island brown kiwi
Apteryx australis [captive
birds: two adults, four
juveniles]
Non-toxic carrot and
cereal bait treated with
EDR
Baits presented at 500
to 1000 times greater
than standard 1080
operation
Some kiwi investigated the baits but no
baits were eaten during four hours of
observation using night vision equipment
over four separate nights.
Speedy CJT
2003
Robins (Petroica australis)
Tomtits (Petroica
macrocephala)
Lake Taupo Forest
0.08% 1080 Carrot
surface coated with
EDR sown at 5 kg/ha
No statistically significant differences in
bird density. Significant difference between
robin populations in treatment and control
areas, due to unexplained decreases in the
control population [possibly severe
weather events and other disturbances]
Oates 2006
Robins (Petroica australis)
Tomtits (Petroica
macrocephala)
Free-ranging birds in field
not previously exposed to
baits
Non-toxic carrot and
cereal bait containing
cinnamon and treated
with EDR, with and
without green dye;
freshly treated and
weathered baits both
used
No significant differences in the number
of pecks at bait with or without EDR
irrespective of age of bait.
Significantly less carrot bait with repellent
was pecked at by robins than carrot
without repellent EDR irrespective of age
of bait.
Only half as much cereal bait was
consumed by robins as carrot due to more
dense texture when dry
Robins frequently pecked baits; tomtits did
not interfere with any bait treatments
Ross et al 2006
Tomtits (Petroica
macrocephala)
Aorangi Forest Park,
Wairarapa
9800 ha 0.08% 1080
Carrot surface coated
with EDR sown at 5
kg/ha
No significant decrease in tomtit
abundance between EDR treated areas and
non-EDR treated toxic bait; no nontreatment sites
Notes that results should not be
extrapolated to other bird species
Ross 2007
Farmed red deer
Six non-toxic cereal
bait types in
combination with
cinnamon lure and/or
deer repellent [EDR]
Intensively farmed deer ate very little cereal
bait surfaced coated with EDR both with
and without cinnamon lure but ate all bait
with no repellent or with repellent
incorporated into the bait – stag ate bait
faster than hinds
Extensively farmed deer ate little bait of
any type until 4th day, with stags eating
more non-repellent than repellent coated
baits
Morriss et al
2003
Wild red deer – Hampden
Otago
800 ha treated with
1080 carrot surface
coated with EDR
Too few deer available in the trial areas to
allow robust assessment of effectiveness
and lack of replication
Lorigan and
Nugent 2002
Wild red deer –
Tataraakina, Hawkes Bay
2000 ha treated with
1080 carrot surface
coated with EDR
Deer repellent reduced mortality in
repellent block to near 0 compared with
non-repellent block with estimated kill of
>50%
Nugent et al
2004
Birds
Deer
ERMA New Zealand Decision: Application HSC07024
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Species being
monitored and location
of trials
Bait type and
application rate
Summary of results
Reference as
listed in
bibliography to
the application
Wild red deer – Hawkes’
Bay
1074 ha cereal bait
treated with EDR
Deer repellent reduced mortality in
repellent block to near 0 compared with
non-repellent block with estimated kill of
59%
Recommendation for further field trials to
include more intensive and quantitative
monitoring of non-target native species
Morris et al
2006
Possums
See above
In the above trials, EDR on carrot or
cereal had no impact on efficacy against
possums
See above
Rodents – Otupua stream
headwaters, tributary of
Mohaka River
0.15% 1080 Cereal
bait treated with EDR
sown at 2 kg/ha
Summer application of bait may limit
conclusions which can be drawn for more
usual winter operations.
Tracking abundance significantly reduced
at treatment sites relative to non-treatment
areas
Replication required under winter
conditions
Lorigan 2006
Target pests
4.28
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 Committee considers that the benefits to be gained from the trial, ie robust
monitoring data, outweigh the risks.
Risks to Human Health and Welfare
4.29
The Committee 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
4.30
The Committee notes that the applicant has consulted with the appropriate iwi/Māori
land owners and interest groups about the containment proposal receiving support and
interest in ongoing involvement. Although there is some uncertainty relating to risks
to native non-target species from the GEDR coating (as outlined in section 4.25) and
therefore to the mauri of those species and ecosystems, the Committee considers that
the role of iwi/Māori as kaitiaki has been preserved by their ongoing involvement in
this containment trial.
4.31
In addition the Committee 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.
ERMA New Zealand Decision: Application HSC07024
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4.32
The Committee 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.
4.33
From the information provided, and considering that the application is for field trials,
the Committee considers that GEDR on 0.15% 1080 Pellets 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.
4.34
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
5.2
The Committee has evaluated the adequacy of the containment arrangements
proposed by the applicant and the controls listed in Appendix 1, and note 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 substances;
 to control the effects of any accidental release of the substances;
 inspection and monitoring requirements;
 qualifications required of the person responsible for implementing the controls.
The Committee 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.
6 Decision
6.1
The Committee has considered this application made under section 31, and pursuant to
section 32, the Committee is satisfied that this application is for the purpose specified in
section 30(b) (research on any hazardous substance to acquire information for use in
assessing that substance in accordance with the Act).
6.2
Having considered the risks associated with the lifecycle of GEDR on 0.15% 1080 Pellets,
the Committee is satisfied that the controls imposed, including those in place under other
legislation, will result in the substance being adequately contained.
ERMA New Zealand Decision: Application HSC07024
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6.3
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, the Committee has applied the criteria specified in section 32 .
6.4
The Committee has also applied the following criteria contained 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.
6.5
The application to manufacture in containment the hazardous substance GEDR on 0.15%
1080 Pellets is thus approved pursuant to section 32, with controls as set out in Appendix
1.
signed
Neil Walter
Date 12 September 2007
Chair
Environmental Risk Management Authority
ERMA New Zealand Approval Code:
GEDR on 0.15% 1080 Pellets:
HSC000287
ERMA New Zealand Decision: Application HSC07024
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Appendix 1: List of controls that apply to the hazardous
substance GEDR on 0.15% 1080 Pellets
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 of EPRO Ltd.
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, or 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
GEDR on 0.15% 1080 Pellets
HSC07024
HSC000
Noel McCardle
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.
ERMA New Zealand Decision: Application HSC07024
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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. This approval remains in place until 31 December 2007.
17. A maximum amount of 18 tonnes of GEDR on 0.15% 1080 Pellets shall be applied to 9000
hectares of treatment area.
ERMA New Zealand Decision: Application HSC07024
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