ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
9 April 2009
Application Code
HSC09003
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant
Connovation Limited
Purpose of the Application
To import or manufacture into containment pellet bait
containing 0.15% 1080 for testing as a potential vertebrate toxic
agent (field trial).
Date Application Received
Consideration Date
11 March 2009
9 April 2009
Considered by
Rob Forlong Chief Executive of ERMA New Zealand
1 Summary of Decision
1.1
The application to manufacture pellet bait containing 0.15% 1080 in containment 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 bait has been given the following unique identifier for the ERMA New Zealand
Hazardous Substances Register:
Pellet bait containing 0.15% 1080 (HSC09003)
2 Purpose of the Application
2.1
The applicant states the purpose of this application is to assess the efficacy of a new
pellet bait containing 0.15% 1080 as a potential multi-species vertebrate toxic agent for
possums, rats and mice.
3 Application process
3.1
The application was formally received on 11 March 2009.
3.2
3.3
Project Team:
Noel McCardle
Senior Advisor (Hazardous Substances).
Greg Kent
Senior Advisor (1080 Coordination)
Patrick Gemmell
Senior Advisor, Maori Group
The applicant supplied the following documents:
 The application; and
 Appendices, containing:
-
3.4
Information on the manufacturing site and manufacturing methods;
Formulation details;
Draft label;
Draft safety data sheet;
Animal Ethics Approvals;
Trial protocols; and
Researchers’ details.
The following government departments were advised of the receipt of the application:
 The Department of Conservation;
 The Department of Labour (Workplace Group);
 The Ministry of Health; and
 The Agricultural and Veterinary Medicines (ACVM) Group of the New Zealand
Food Safety Authority (NZFSA).
3.5
No comments from the Agencies were received.
3.6
The pellet bait is being developed as a multi-species bait for possum, rats and mice.
Animal Ethics Applications have been submitted to the Lincoln University Animal
Ethics Committee and approved. An application for a provisional approval has also
been submitted to the ACVM Group (New Zealand Food Safety Authority).
3.7
The applicant was provided with a copy of the proposed controls for the pellet bait and
given the opportunity to comment on them. The applicant raised no issues with the
proposed controls.
4 Consideration
Eligibility
4.1
As the purpose (see section 2.1) amounts to “research on any hazardous substance to
acquire information for use in assessing that substance”, the project team considers that
the application qualifies for consideration under section 30(b).
ERMA New Zealand Decision: Application HSC09003
Page 2 of 8
Lifecycle
4.2
The pellet bait is to be manufactured at the Connovation Limited premises located at
36B Sir William Ave. East Tamaki. This is a secure facility and the product will be
made within the facility by or under the supervision of a person with an appropriate
Approved Handler certificate for substances containing 1080. The product is to be
stored locked up and in labelled polypail containers secured with tamper evident lids.
4.3
The polypails containing bait will be transported off-site to a laboratory (see 4.4) and
South Island storage site (prior to delivery to trial site) by using an approved Dangerous
Goods chemical courier. The laboratory and South Island storage sites will provide
secure storage of the product. The pellet bait will be taken by Connovation research
staff from secure storage to the study site. These person(s) will have an Approved
Handler certificate and Controlled Substances Licence.
4.4
Prior to commencement of the field trials sample pellet bait will be sent to the
Toxicology Laboratory, Landcare Research, for analysis of the 1080 content.
4.5
There are two intended field trial sites, one in the North Island and the other in the South
Island. Both sites have been chosen as access by the public is limited, there is no
domestic stock on the sites and there are no nearby waterways. The North Island site is a
12 hectare privately owned bush area and the trial will be in a 170 x 135 m area. The
South Island site is a pine plantation area and the trial site is 1000 m x 500 m. A control
area (no toxic bait laid) will also be used for the assessment of the effectiveness of the
pellet bait.
4.6
Signage will be put in place at the main entry points to the trial sites prior to and during
the trial, as a warning to persons that may be in that area.
4.7
Bait stations will be placed in a grid over the trial sites. Monitoring with tracking
cards, tracking tunnels, wax tags and bird counts after laying non-toxic bait (same bait
matrix but without the 1080 active) will be carried out prior and then following the
toxic baiting to establish the types/numbers of terrestrial vertebrates in the area and
visiting the bait stations.
4.8
The trials will allow for the toxic pellet bait to be available in the bait stations for 4-days
Research staff will check the trial sites daily in order to remove any dead carcasses.
4.9
Commercial bait stations will be attached to trees (200 mm above ground level) and
hold up to 1 kg of pellets. Shade cloth will be laid from the bait station entrance to the
ground to allow access for small target pests (rats, mice).
4.10
All signage at entry points to the study area will be removed after baits have been
removed from the site on completion of the trial.
4.11
All uneaten pellet baits will be removed from bait stations at the end of the trials and
disposed of through an approved waste management company. Any dead carcasses that
are found will be recovered, bagged and then disposed of off-site to an approved landfill
ERMA New Zealand Decision: Application HSC09003
Page 3 of 8
or approved offal pit or by incineration. The bait stations will be removed from the trial
sites.
4.12
Gloves and overalls will be put into a plastic bag and then washed (separate to
household laundry) and dried before re-use.
Hazardous properties
4.13
Cereal based 1080 baits have the HSNO Approval Code: HSR002424. The hazardous
classifications are 6.1B (oral), 6.1C (inhalation), 6.8A, 9.1D and 9.3A.
4.14
Only the 1080 component is considered to have hazardous classifications and be present
at a concentration that would contribute to the overall classification of the pellet bait.
Containment and controls
4.15
The applicant has proposed containment measures to minimise the risks associated with
the proposed manufacture and field trials.
4.16
In addition, the project team considers that the controls that apply to cereal based 1080
baits under approval no. HSR002424 should apply to these containment trials.
4.17
The project team considers that the following controls should also apply:
4.18

A requirement to approach the local Health Protection Unit to ensure a permission
is not required.

A requirement that the applicant supplies a copy of the tracking records for
substances and packages, including a requirement to record the name of the
Controlled Substances Licence holder.

A requirement to report spillages, misapplications, loss of any quantity.

A requirement to report incidents (e.g. dog deaths).
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 substance or
contamination by hazardous substances;

to exclude organisms from a facility;

to exclude unauthorised people from the facility;

to prevent unintended release of the substance 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.
ERMA New Zealand Decision: Application HSC09003
Page 4 of 8
4.19
Taking into account the containment measures proposed, the project team considers any
likely impact of the substance on the relationship of Māori to their ancestral lands,
water, sites, waahi tapu, valued flora and fauna and other taonga to be negligible. In
addition, because of the nature of the testing regime there is no evidence to suggest that
the controlled use of this substance will breach the principles of the Treaty of Waitangi
or inhibit the ability of iwi/ Māori to fulfil their role as kaitiaki.
4.20
The project team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, the baits can be adequately
contained.
5 Decision
5.1
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(b), namely
research on any hazardous substance to acquire information for use in assessing that
substance.
5.2
Having considered the risks associated with the lifecycle of Pellet bait containing 0.15%
1080 (HSC09003), I am satisfied that the controls imposed, including those in place
under other legislation, will result in the substance being adequately contained.
5.3
The application to manufacture in containment the hazardous substance Pellet bait
containing 0.15% 1080 (HSC09003) is thus approved with controls as set out in Appendix
1 and in accordance with the relevant provisions of the Act and the Methodology as
more specifically set out in Appendix 2.
signed
Rob Forlong
Date: 9 April 2009
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Pellet bait containing 0.15% 1080 (HSC09003)
ERMA New Zealand Decision: Application HSC09003
HSC000365
Page 5 of 8
APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
Pellet bait containing 0.15% 1080 (HSC09003)
General
1.
The trials shall be undertaken in accordance with the Trial Protocols (provided in
the confidential appendix to the application) and the information specified within
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.
The controls that apply to cereal based pellets containing 1.5–2.0 g sodium
fluoroacetate/kg (HSNO Approval Number: HSR002424) shall apply to pellet bait
containing 0.15% 1080 (HSC09003).
3.
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.
4.
Notwithstanding the requirements of controls 1 and 2 above, the manufacture and
trials shall also comply with the following controls:
Manufacture
5.
Connovation Ltd shall manufacture a maximum of 40 kg of pellet bait containing
0.15% 1080 (HSC09003) under this approval.
Transport
6.
Transportation of the substances will be by a qualified dangerous goods courier or
by Connovation research staff who have approved handler certificates and
controlled substances licences.
Trial Sites
7.
The field trials shall be carried out in areas identified in the confidential section of
the application.
8.
Access to the trial sites shall be by landowner’s permission only.
9.
The trial sites shall have warning signs displayed at each of the points of entry
during the period that toxic bait is applied and for 6 months or until the bait and any
animal carcasses are recovered. The warning signs shall comply with the details as
specified in the Trial Protocols in the confidential appendix to the application.
10.
Connovation Ltd shall approach the local Health Protection Unit to ensure a
permission is not required.
ERMA New Zealand Decision: Application HSC09003
Page 6 of 8
Trial Conditions
11.
During use the baits shall be under the control or supervision of an Approved
Handler with certification for vertebrate toxic agents and who must hold a
Controlled Substances Licence. Experimental staff shall be trained and experienced
in the handling and administration of vertebrate toxic agents under test conditions
using the specified equipment. Experimental staff should also be aware of the trial
protocols and the controls in place in order to adequately manage the substance.
Notification and Inspection
12.
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
Pellet bait containing 0.15% 1080 (HSC09003)
HSC09003
HSC000365
Noel McCardle
13.
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.
14.
Trial documentation, as described in Control 1, notwithstanding its confidential
nature, shall be available for inspection by any enforcement officer, upon request.
Monitoring and Reporting
15.
Connovation Ltd shall supply ERMA New Zealand with a copy of the tracking
records for the bait and packages. The tracking records shall identify the Controlled
Substances Licence holder who is in possession of the pellets.
16.
At the conclusion of the trials, Connovation Ltd shall report spillages,
misapplications and the loss of any quantity of pellet bait containing 0.15% 1080
(HSC09003) to ERMA New Zealand.
17.
At the conclusion of the trials, Connovation Ltd shall report incidents (e.g. dog
deaths) to ERMA New Zealand.
ERMA New Zealand Decision: Application HSC09003
Page 7 of 8
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 HSC09003
Page 8 of 8