ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
18 March 2008
Application Code
HSC08002
Application Type
Applicant
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Connovation Ltd
Purpose of the Application
To assess the effects of Feratox on wallabies (cage/pen trials).
Date Application Received
13 February 2008
Consideration Date
18 March 2008
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, Feratox, 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:
Feratox for wallabies (in containment)
2 Purpose of the Application
2.1
The applicant states the purpose of this application is to allow for testing of an
existing approved substance (HSR001673) containing potassium cyanide at 475
g/kg but in a different delivery form. This application will allow testing on wallaby
species. These are larger target animals than possums for which the current Feratox
product is used. Testing on these species will be undertaken in cage/pen trials to
determine the required dose rate and optimise the delivery form (pellet size and bait
station).
3 Application process
3.1
The application was formally received on 13 February 2008.
3.2
3.3
Project Team:
Haydn Murdoch
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit
Beth Dye
Applications Manager (Hazardous Substances).
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing information regarding:
-
3.4
the manufacturing site and methods;
certification of the manufacturing site;
description of Connovation Ltd procedures, facilities and management;
information on what records will be kept;
a copy of the Animal Ethics Committee applications for trials on Dama
wallabies and Bennett’s wallabies;
The following government departments were advised of the receipt of the
application and given the opportunity to comment:
 The Department of Conservation;
 The Ministry of Health;
 The Department of Labour (Workplace Group); and
 The Agricultural and Veterinary Medicines (ACVM) Group of the New Zealand
Food Safety Authority (NZFSA).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for Feratox and
given the opportunity to comment on them. The applicant’s comments were
incorporated into the final controls.
4 Consideration
Eligibility
4.1
As the purpose (see section 2.1) 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 advises that the substance will be dealt with throughout its lifecycle
in the following way:
ERMA New Zealand Decision: Application HSC08002
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4.2.1
Containment conditions will be given to all people involved in the
manufacture, use, storage and disposal of the experimental product. The
overall trial will be supervised by the applicant’s Study Supervisor who is
an Approved Handler.
Manufacture
4.2.2
Feratox pellets will be manufactured at the Connovation Limited premises
located at 36B Sir William Ave. East Tamaki. This is the same facility
used for manufacture of the pellets covered by HSR001673. All the
components required are available on site and used for the existing
approved product. The only deviation will be in the manufacturing process
in order to make different form/dimension/weight of pellets.
4.2.3
This is a secure facility and the product will be made and stored in the
secure laboratory within the facility and under the control of a person with
an appropriate Approved Handler certificate for substances that are highly
toxic and used as Vertebrate Toxic Agents. The product will be stored in
labelled HDPE containers with screw tops.
Transportation
4.2.4
The transportation of the Feratox pellets off-site to the analytical
laboratory or Study Supervisor and then to the study sites, will be in a
labelled screw top container within a Dangerous Goods Management box
and in accordance with all Land Transport Rules.
4.2.5
The Feratox pellets will also need to be transported to the two animal test
facilities. The Study Supervisor has an Approved Handler Certificate and
will store the pellets under lock and key when not being used for the trials.
Analytical Studies
4.2.6
Prior to commencement of the trials a sample of Feratox will be sent to the
Toxicology Laboratory, Landcare Research, for analysis of the potassium
cyanide content. Procedures will be in place to store and handle products
securely.
Animal Studies
4.2.7
Two trials at different facilities are planned on two wallaby species. The
studies will be undertaken on a limited number of animals at the two sites.
Applications for approval by Animal Ethics Committees have been made
and these are included in the confidential section of the application
(Appendix A – Sections 3 and 4). Information on how the trials will be
conducted, by whom and where are covered in these applications.
4.2.8
The Feratox Safety Data Sheet and a cyanide first aid kit will be available
on-site during the trials. The trials will be overseen by an experienced
Connovation staff member.
ERMA New Zealand Decision: Application HSC08002
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4.2.9
The facilities are secure and procedures are in place to ensure containment;
keeping test animals within the test environment and unauthorised
personnel out of the facilities. The Feratox pellets will be provided to test
animals under controlled conditions, i.e. in controlled containment
facilities (note that at the Bennett’s wallaby study, baits will be placed in a
bait bowl), with study personnel observing effects on animals etc.
4.2.10
All untaken pellets will be recovered from the bait stations and are to be
placed in a sealed labelled plastic container. All untaken or unused pellets
will be returned to Connovation Ltd for disposal.
4.2.11
Domestic animals are excluded from the study sites. These sites are fully
contained and secure, totally exclude domestic stock and have been chosen
to minimise potential exposure to domestic animals/pets and access by the
public.
Disposal
4.2.12
Any unused or untaken toxic pellets will be returned to Connovation for
disposal in accordance with local by-laws through Transpacific Technical
Services Limited (formerly United Environmental Ltd).
4.2.13
Animal carcasses will be disposed of by burying in a biologically active
landfill or an approved offal hole.
4.2.14
Gloves and overalls will be put into a plastic bag and then washed
(separate to household laundry) and dried before re-use. If disposable
gloves and overalls are used, these will be placed in a sealed bag and
disposed of in a landfill.
Hazardous properties
4.3
The applicant has examined the hazardous nature of the pellets and considers them
to trigger the following hazard classifications:
 Acute oral toxicity (6.1B)
 Skin irritancy (6.3B)
 Eye irritancy (6.4A)
 Skin sensitisation (6.5B)
 Reproductive/developmental toxicity (6.8B)
 Target organ systemic toxicity (6.9A)
 Aquatic ecotoxicity (9.1A)
 Soil ecotoxicity (9.2A)
 Terrestrial vertebrate ecotoxicity (9.3A)
 Terrestrial invertebrate ecotoxicity (9.4A)
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4.4
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 containment controls.
Identification and evaluation of the significant risks of the substance in
containment
4.5
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
4.6
The proposed substance is highly ecotoxic to the environment. If released into the
environment the substance has the potential to result in adverse effects on nontarget species.
4.7
On the basis of the lifecycle of the substance adverse environmental effects could
arise from:
 an accident during storage, use or transportation, resulting in release of the
pellets;
 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 the
pellets; or
 failure to follow correct disposal procedures.
4.8
The Project Team has considered the highly ecotoxic properties of the substance,
the quantities required for the trials (≤1kg), the controls listed in Appendix 1 of this
decision and requirements under other legislation. Based on these considerations,
the Project Team considers that risks to the environment from this trial can be
adequately managed.
Risks to human health and welfare
4.9
The Project Team considers that adverse effects to human health and welfare may
result from exposure to the pellets, given that the substance has highly toxic
properties.
4.10
On the basis of the lifecycle of the substance adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the
pellets;
 failure to follow the correct operational procedures as set out in the controls and
the containment system, resulting in personnel exposure while contained; or
 failure to follow correct disposal procedures.
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4.11
The Project Team has considered the toxic properties of the substance, the quantities
required for the trials (≤1kg), the containment regime proposed by the applicant, the
controls in Appendix 1 of this decision and requirements under other legislation. The
applicant has given specific consideration to the fact that Feratox contains a highly
toxic substance. Provisions to avoid risk to human health include approved handler
requirements, personal protective equipment, and information requirements. Based on
these considerations, the Project Team considers that risks to human health and
welfare can be adequately managed.
Māori issues and concerns
4.12
The Project Team considered this application using the framework contained in the
ERMA New Zealand user guide “Working with Māori under the HSNO Act 1996”.
4.13
The applicant and the Project Team noted that Feratox triggers HSNO thresholds for
toxicity and ecotoxicity and may therefore have adverse effects on the relationship of
Māori to the environment, particularly with regard to the mauri of native and/or
valued species and ecosystems.
4.14
The Project Team notes that the trial sites are within known research facilities and the
test animals are introduced species and therefore specific consultation with Maori/iwi
is not required.
4.15
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.
4.16
This assessment is made on the condition that the substance is handled, stored,
transported, used, and disposed of as outlined in the applications for ethics approval
and 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 Connovation Ltd 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
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;
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5.2

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.
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, the pellets can be adequately
contained.
6 Decision
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 Feratox, 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 substance Feratox 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.
Rob Forlong
Date: 18 March 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Feratox for wallabies (in containment)
ERMA New Zealand Decision: Application HSC08002
HSC000325
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
FERATOX
General
1.
The trials shall be undertaken in accordance with the details provided in the
applications for Animal Ethics Committee approvals (provided in sections 3 and 4
of the Confidential Appendix to the application) and the information specified
within section 4 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.
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.
3.
Notwithstanding the requirements of control 1 above, the manufacture and trials
shall also comply with the following controls:
Manufacture
4.
Connovation Ltd shall manufacture a maximum of 1kg of Feratox for the wallaby
trials at the Connovation Ltd premises in Auckland under this approval.
Packaging and Information
5.
The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
6.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001.
7.
The labels must also set out instructions that any of the pellets remaining after the
trials must be returned in the original container to Connovation Ltd.
8.
Safety Data Sheets, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each despatch of the substance and be held at
the trial sites for the duration of the application.
Storage
9.
The pellets shall be held in locked storage when not in use.
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Transport
10.
The substance shall be transported in compliance with any relevant requirements of
the Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 and
the Maritime Transport Act 1994.
General Handling of the Substance
11.
Personal Protective Equipment (e.g. glasses, gloves and protective clothing) shall
be worn when handling the substance (e.g. during manufacture, bait analysis, use
and disposal).
Trial Sites
12.
The trials on Dama wallabies shall be carried out as identified in the confidential
section of the application (Appendix A - Section 3).
13.
The trials on Bennett’s wallabies shall be carried out as identified in the
confidential section of the application (Appendix A - Section 4).
14.
Access to the trial sites shall be by permission of the Study Directors1 or researcher
nominated by the Study Directors. The trial sites shall be signed indicating that
unauthorised access is not permitted, that the site is subject to a trial, and that trial
animals and other animals should not be removed.
Trial Conditions
15.
During use the pellets shall be under the control or supervision of an Approved
Handler who has 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.
16.
The location of the Feratox pellets shall be recorded at each stage of the lifecycle
from manufacture to disposal.
Emergency Management
17.
Any accidental spillage of the substance shall be contained, and placed in an
appropriate container. These containers shall be returned to Connovation Ltd for
disposal.
1
The Study Director is the individual appointed by the applicant to be responsible for the overall conduct of a
trial in accordance with information provided in Appendix A of the application and the approval controls.
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Disposal
18.
Any surplus substance remaining at the end of the trials shall be returned to
Connovation Ltd where it shall 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.
19.
Disposal shall be carried out in a manner compliant with the Hazardous Substances
(Disposal) Regulations 2001. Ultimately, this would involve treating the substance
in a manner to render the substance, as a whole, non-hazardous; or exporting the
substance from New Zealand.
20.
Dead wallabies will be disposed of by burying in a biologically active landfill or an
approved offal hole.
Notification and Inspection
21.
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
Feratox (in containment)
HSC08002
HSC000325
Haydn Murdoch
22.
If for any reason a breach of containment occurs, the Study 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.
23.
Trial documentation, as described in Control 1, notwithstanding its confidential
nature, shall be available for inspection by any enforcement officer, upon request.
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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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