ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
3 November 2008
Application Code
HSC08027
Application Type
To import into containment, or manufacture in containment, a
hazardous substance under Section 31 of the Hazardous
Substances and New Organisms Act 1996 (“the Act”)
Connovation Ltd
Applicant
Purpose of the Application
To import into containment, or manufacture in containment,
potential vertebrate toxic agent baits containing either a single
toxin or combinations of two toxins to undertake cage or pen
trials on a range of potential target species (cage/pen trials).
Date Application Received
7 October 2008
Consideration Date
3 November 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of Decision
1.1
The application to manufacture in containment or to import into containment the
hazardous substances, NPAS, NPOW, NCER, NEXT, PPAS, PPOW and PCER, 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 substances have been given the following unique identifiers for the ERMA
New Zealand Hazardous Substances Register:
NPAS
NPOW
NCER
NEXT
PPAS
PPOW
PCER
2 Purpose of the Application
2.1
The applicant states the purpose of this application is to allow for the development
and testing of potential vertebrate toxic agents. The application also includes
options of different bait types/doses to be tested on a range of species in cage/pen
trials.
3 Application process
3.1
The application was formally received on 7 October 2008.
Project Team:
3.2
Haydn Murdoch
Advisor (Hazardous Substances)
Cora Drijver
Advisor (Hazardous Substances)
Noel McCardle
Senor Advisor (Hazardous Substances).
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing information regarding:
-
3.3
the manufacturing site, methods and quantities required to be manufactured;
certification of the manufacturing site;
description of Connovation Ltd procedures, facilities and management;
information on what records will be kept;
proposed formulations and their preliminary hazard classifications;
trial protocols;
a copy of the Animal Ethics Committee applications for trials.
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).
3.4
No responses were received.
3.5
The applicant was provided with a copy of the proposed controls for NPAS,
NPOW, NCER, NEXT, PPAS, PPOW and PCER and given the opportunity to
comment on them. The applicant’s comments were considered when finalising the
controls.
ERMA New Zealand Decision: Application HSC08027
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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).
Lifecycles
4.2
The applicant advises that the substances will be dealt with throughout their
lifecycles in the following way:
Manufacture
4.2.1
The substances identified as NPAS, NPOW, NCER, PPAS, PPOW and
PCER will be manufactured at the Connovation Limited premises located
at 36B Sir William Ave. East Tamaki. This is a secure facility and the
substances will be made and stored in the secure laboratory at this location
and under the control of a person with an Approved Handler certificate for
substances that are highly toxic and used as Vertebrate Toxic Agents. The
products will be stored in separate labelled HDPE containers with screw
tops.
4.2.2
As each cage or pen trial is undertaken sufficient bait for that trial will be
dispatched to the test facility.
4.2.3
The NEXT bait will be imported by a research laboratory under a MAF
Biosecurity permit. Approval will be obtained to transport this substance to
alternative sites and for undertaking the proposed pen trials.
Transportation
4.2.4
The transportation of the substances off-site to the analytical laboratory or
Study Supervisors 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 (NZS 5433:2007).
Analytical Studies
4.2.5
Prior to commencement of the trials a sample of each substance will be
sent to the Toxicology Laboratory, Landcare Research, for any required
analysis. Procedures will be in place to store and handle products securely.
ERMA New Zealand Decision: Application HSC08027
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Animal Studies
4.2.6
The studies to be undertaken are summarised in the following table:
Substance
Identifier
Code
NPAS
NPOW
NCER
NEXT
PPAS
PPOW
PCER
4.2.7
Test animal
Rat
yes
yes
yes
yes
yes
yes
Pig
yes
yes
yes
yes
yes
yes
yes
Possum
yes
yes
yes
-
Dama wallaby
yes
yes
yes
yes
yes
yes
yes
All studies have Animal Ethics Committee approvals and the trial
procedure/containment procedures have been outlined in the Confidential
Appendices to the application.
Disposal
4.2.8
Any unused or untaken toxic baits will be returned to Connovation for
disposal in accordance with local by-laws through Transpacific Technical
Services Limited.
4.2.9
Gloves and overalls will be put into a plastic bag and then washed
(separate to household laundry) and dried before re-use.
4.2.10
Any dead animals will be disposed of by approved waste management
companies. In some instances, e.g. possums, pigs, wallaby, the heads and
stomachs will be disposed of separately through the waste company while
the remaining carcass is put in an approved offal pit or buried in a landfill
if it is available.
Hazardous properties
4.3
The applicant has examined the hazardous nature of the substances and considers
them to trigger the following hazard classifications:
Hazardous property
6.1 Acute toxicity
Bait classification
6.1B PPAS, PPOW, PCER
6.1C NPAS, NPOW, NCER
6.1D NEXT
6.3 Skin irritancy
6.4 Eye irritancy
6.5 Sensitisation
6.6 Mutagenicity
6.7 Carcinogenicity
6.4A NPAS, NPOW, NCER
6.6B NPAS, NPOW, NCER, NEXT
-
ERMA New Zealand Decision: Application HSC08027
Page 4 of 12
6.8 Reproductive/developmental toxicant
-
6.9 Target organs/systems
6.9B NPAS, NPOW, NCER, NEXT
9.1 Aquatic toxicity
9.1A NPAS, NPOW, NCER
9.1B NEXT
9.3A PPAS, PPOW, PCER
9.3B NPAS, NPOW, NCER
9.3C NEXT
-
9.2 Soil ecotoxicity
9.3 Terrestrial vertebrates
9.4 Terrestrial invertebrates
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 lifecycles of the substances in New Zealand can
be managed through the application of containment controls.
Identification and evaluation of the significant risks of the substances 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 substances are highly ecotoxic to the environment. If released into
the environment the substances have the potential to result in adverse effects on
non-target species.
4.7
On the basis of the lifecycles of the substances, adverse environmental effects could
arise from:
 an accident during storage, use or transportation, resulting in release of the
substances;
 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
substances; or
 failure to follow correct disposal procedures.
4.8
The Project Team has considered the highly ecotoxic properties of the substances,
the quantities required for the trials (≤ 10 kg), 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.
ERMA New Zealand Decision: Application HSC08027
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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 substances, given that the substances have highly toxic
properties.
4.10
On the basis of the lifecycles of the substances, adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the
substances;
 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.
4.11
The Project Team has considered the toxic properties of the substances, the quantities
required for the trials (≤ 10 kg), 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 NPAS, NPOW, NCER,
NEXT, PPAS, PPOW and PCER contain highly toxic substances. 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 NPAS, NPOW, NCER, NEXT, PPAS,
PPOW and PCER trigger 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 substances 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 these substances 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 substances are 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
ERMA New Zealand Decision: Application HSC08027
Page 6 of 12
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
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 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.
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, the substances can be adequately
contained.
ERMA New Zealand Decision: Application HSC08027
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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 lifecycles of NPAS, NPOW, NCER,
NEXT, PPAS, PPOW and PCER, I am satisfied that the controls imposed, including
those in place under other legislation, will result in the substances being adequately
contained.
6.3
The application to manufacture in containment, or to import into containment, the
hazardous substances NPAS, NPOW, NCER, NEXT, PPAS, PPOW and PCER 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: 3 November 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
NPAS
NPOW
NCER
NEXT
PPAS
PPOW
PCER
ERMA New Zealand Decision: Application HSC08027
HSC000344
HSC000345
HSC000346
HSC000347
HSC000348
HSC000349
HSC000350
Page 8 of 12
APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
NPAS, NPOW, NCER, NEXT, PPAS, PPOW AND PCER
General
1.
The trials shall be undertaken in accordance with the details provided in the trial
protocols and Animal Ethics Committee approvals (provided in section 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, importation
and trials shall also comply with the following controls:
Manufacture/Importation
4.
Connovation Ltd shall manufacture a maximum of 2.5 kg each of NPAS, NPOW
and NCER and 2 kg each of PPAS, PPOW and PCER at the Connovation Ltd
premises in Auckland under this approval.
5.
Connovation Ltd shall import a maximum of 8 kg of NEXT under this approval.
Packaging and Information
6.
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
7.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001.
8.
The labels must also set out instructions that any of the substances remaining after
the trials must be returned in the original container to Connovation Ltd.
9.
Safety Data Sheets, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each despatch of the substances and be held at
the trial sites for the duration of the application.
Storage
10.
The substances shall be held in locked storage when not in use.
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Transport
11.
The substances 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 Substances
12.
Personal Protective Equipment (e.g. glasses, gloves and protective clothing) shall
be worn when handling the substances (e.g. during manufacture, bait analysis, use
and disposal).
Trial Sites
13.
The trials shall be carried out at the locations specified in Section 4 of the
Confidential Appendix to the application.
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 substances 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 substances.
16.
The location of the NPAS, NPOW, NCER, NEXT, PPAS, PPOW and PCER shall
be recorded at each stage of their lifecycles from manufacture/importation to
disposal.
Emergency Management
17.
Any accidental spillage of the substances shall be contained, and placed in an
appropriate container. These containers shall be returned to Connovation Ltd for
disposal.
Disposal
18.
Any surplus substances remaining at the end of the trials shall be returned to
Connovation Ltd where it shall be securely stored in a laboratory complying with
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.
ERMA New Zealand Decision: Application HSC08027
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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
substances in a manner to render the substances, as a whole, non-hazardous; or
exporting the substances from New Zealand.
20.
Any dead animals 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(s)
ERMA Application number
ERMA Approval number(s)
ERMA Applications Advisor
NPAS, NPOW, NCER, NEXT, PPAS, PPOW
and PCER
HSC08027
HSC000344 to HSC000350
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.
ERMA New Zealand Decision: Application HSC08027
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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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