ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
1 March 2005
Application Code
HSC04039
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996.
Applicant
Pest-Tech Ltd.
Purpose of the Application
To import or manufacture new baits for the control of
possums, and assess them in replicated field trials.
Date Application Received
17 January 2005
Consideration Date
28 February 2005
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substances Cholcalciferol
Polymer and Cholcalciferol Fruit Jubes is approved with controls in accordance with
the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the
HSNO Act) and the HSNO (Methodology) Order 1998.
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Cholcalciferol Polymer
Cholcalciferol Fruit Jubes
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the HSNO Act. 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 HSNO Act and the provisions of Part III of the Third Schedule of
the HSNO Act. Unless otherwise stated, references to section numbers in this decision
refer to sections of the HSNO Act.
2.2
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology). Unless
ERMA New Zealand Decision: Application HSC04039
Page 1 of 8
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 17 January 2005 and assessed as having
sufficient information on 28 January 2005.
3.2
Project Team:
Nicola Reeves
Advisor (Hazardous Substances)
Sue Thomas
Senior Advisor (Toxicology)
Zack Bishara
Māori Policy Advisor
Report review and sign-out by:
Beth Dye
Programme Manager, Applications (Hazardous
Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices.
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 Department of Labour (Occupational Safety and Health)
 The Agricultural Compounds and Veterinary Medicines (ACVM) Group of the New
Zealand Food Safety Authority.
3.5
The following comment was received from the ACVM Group:
“As these substances will be considered under the ACVM Act, any issues which may
arise and the Acts administered by MAF/NZFSA will be considered as part of these
applications.”
3.6
The applicant was provided with a copy of the proposed controls for Cholcalciferol
Polymer and Cholcalciferol Fruit Jubes and given the opportunity to comment on them.
No comments were received.
4
Consideration
Sequence of the Consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under
delegated powers from the Authority (section 19(2)(e) of the HSNO Act).
ERMA New Zealand Decision: Application HSC04039
Page 2 of 8
4.2
In accordance with section 32 of the Act, 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 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.
Purpose of the Application
4.3
The purpose of the application is to import or manufacture new baits for the control of
possums, and assess them in replicated field trials.
4.4
As the purpose amounts to “research and development on any hazardous substance to
acquire information for use in assessing that substance for a HSNO approval”, I
consider that the application qualifies for consideration under section 30(ba) of the Act.
Life Cycle
4.5
Pest-Tech Ltd plans to manufacture the Cholcalciferol Polymer and Cholcalciferol Fruit
Jubes baits in containment in a warehouse. Manufacture of the baits involves mixing
the toxicants into a cereal mix with a 40-quart mixer and then extruding into polymer
baits weighing 20g with a single-screw extruder.
4.6
Manufactured baits will then be stored in a locked storeroom until transport to the trial
site in a locked compartment of a vehicle.
4.7
The applicant has identified the field trials will be undertaken on Department of
Conservation estate and Carter-Holt Harvey Forest. At these sites the baits will be
presented in bait stations. The stations will be set in two transects, the first at the forest
margin and the second 300 metres from the forest edge. Stations will be placed at 50
metre intervals along transects. The trial will be conducted over an 18 month period.
4.8
The bait stations will be designed to limit exposure of non-target species and possums
feeding at the stations are not expected to remove the bait or discard significant
amounts onto the ground.
4.9
At the end of the trial remaining bait will be removed from the field trial site and stored
in a locked poisons store at Pest-Tech until subsequent disposal. The applicant indicates
that the baits will be disposed of by Dakins, a company which specialises in handling
toxic substances.
Hazardous Properties
4.10
I note that a containment application only requires sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls.
4.11
The applicant has assessed the available information and has identified that baits
containing cholcalciferol are acutely toxic via the oral route. Cholcalciferol may be
absorbed through the skin, but the applicant states that the dermal toxicity of the
substance is low. Additionally the applicant states that, cholcalciferol containing baits
ERMA New Zealand Decision: Application HSC04039
Page 3 of 8
are ecotoxic, with non-target terrestrial species being susceptible to the toxicant.
Cholcalciferol is not water soluble and therefore a significant risk is not expected if
spillage of the baits into waterways occurred.
4.12
The applicant has identified that in addition to primary poisoning of non-target species
there is potential for secondary poisoning through scavenging of possum carcasses or
predation of rodents that have directly eaten the bait.
4.13
The applicant states that during previous field trials they have undertaken there have
been no reported deaths of birds, cats or dogs.
4.14
I have reviewed the applicant’s hazard information and consider that it is sufficient to
describe the hazards associated with the substances to ensure that any risks can be
managed by the containment controls.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.15
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential
risks of escape from containment under the headings of environmental, human health
and welfare and Māori issues and concerns.
4.16
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of risk management. I have reviewed the applicant’s
assessment of the risks and agree that it is suitable for the consideration below.
Risks to the Environment
4.17
If released into waterways, the substances have the potential to result in adverse effects
on aquatic organisms. Additionally the baits are toxic via the oral route to non-target
terrestrial species including birds and dogs.
4.18
On the basis of the lifecycle of the substance outlined in paragraphs 4.5 to 4.9, adverse
effects could arise from:
 An accident during transportation, storage, or use resulting in release of the
substance
 Failure to follow correct disposal procedures, as outlined by the applicant.
4.19
I consider that, taking into account the application of these baits using bait stations, the
storage controls in Appendix 1, the provision made for the disposal of remaining
substance, the poor solubility of the toxicant and the Approved Handler requirements,
there are no significant risks to the environment.
Risks to Human Health and Welfare
4.20
If the substances are ingested or come into contact with skin there is the potential for
adverse effects on human health to occur.
4.21
On the basis of the lifecycle of the substances outlined in paragraphs 4.5 to 4.9, adverse
effects could arise from:
ERMA New Zealand Decision: Application HSC04039
Page 4 of 8


4.22
An accident during transportation, storage, or use resulting in exposure to the
substance
Failure to follow correct disposal procedures, as outlined by the applicant.
I consider that, taking into account the restricted access to the field trial site, the
packing and storage controls in Appendix 1, the provision made for the disposal of
remaining substance, the requirement to wear chemical resistant gloves when handling
the baits and the Approved Handler requirements, there are no significant risks to
human health and welfare.
Māori issues and concerns
4.23
I have considered the potential Māori cultural effects of this application in accordance
with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework
contained in the ERMA New Zealand User Guide “Working with Māori under the
HSNO Act 1996”.
4.24
On the basis of the information provided by the ERMA New Zealand Advisor (Māori),
I consider that the substance is unlikely to have an impact on the relationship of Māori
and their culture and 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 controls in Appendix 1, and in accordance with any other
relevant controls applied under other legislation.
5
Containment and Controls
5.1
I have 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 (for example, controls 12)
 To exclude organisms from a facility (for example, control 12)
 To exclude unauthorized people from the facility (for example, control 5 and 9)
 To prevent unintended release of the substances by experimenters working with the
substance (for example, control 8)
 To control the effects of any accidental release of the substance (for example,
control 8)
 Inspection and monitoring requirements (for example, control 20)
 Qualifications required of the person responsible for implementing the controls (for
example, control 16)
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, Cholcalciferol Polymer and Cholcalciferol
Fruit Jubes can be adequately contained.
ERMA New Zealand Decision: Application HSC04039
Page 5 of 8
6
Decision
6.1
I have considered this application under section 31 to import into containment
hazardous substances, and pursuant to section 32, I am satisfied that this application is
for the purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of Cholcalciferol Polymer and
Cholcalciferol Fruit Jubes, I am satisfied that the controls imposed, including those in
place under other legislation, will result in the substances being adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology I record that, in reaching this
conclusion, I have applied the criteria specified in section 32 of the Act.
6.4
I have also applied the following criteria 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 import into containment the hazardous substances Cholcalciferol
Polymer and Cholcalciferol Fruit Jubes is thus approved pursuant to section 32 of the
Act, with controls as set out in Appendix 1.
Bas Walker
Date 1 March
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Cholcalciferol Polymer:
Cholcalciferol Fruit Jubes:
HSC000147
HSC000146
ERMA New Zealand Decision: Application HSC04039
Page 6 of 8
Appendix 1: List of controls that apply to the
hazardous substances Cholcalciferol Polymer and
Cholcalciferol Fruit Jubes
1. The trial shall be conducted only for the purpose stated in the application and shall be
undertaken in accordance with the details supplied to ERMA New Zealand in the
application form. Modifications to the proposed trial may be approved in writing by
ERMA New Zealand providing that they comply with the following controls.
2. Notwithstanding the requirements of control 1 above, the trials shall also comply with the
following controls:
3. The trial shall only be undertaken on Department of Conservation estate and Carter-Holt
Harvey Forest, identified in the application as the site of the trial.
4. Prior to manufacture of the baits, all toxicants shall be stored in a locked poisons store.
5. Manufacture of the baits shall be limited to an enclosed building. Once manufactured, the
baits shall be stored in a locked storeroom.
6. Access to the locked stores shall be restricted to approved personnel.
7. While in storage and during transport the baits shall be securely packed in suitable
containers that comply with the Hazardous Substances (Packaging) Regulations 2001,
and shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001. Information on appropriate safety precautions necessary to provide
safeguards against the substances’ toxic properties shall accompany the substances.
8. Baits shall be transported in a lockable compartment of a vehicle. Any spillage of bait
that occurs during transport shall be swept up and contained in bags or bins for disposal.
9. Access to the forest trial site area shall be by permitted access only for the duration of the
trial.
10. Landowners in adjoining properties to the trial site shall be contacted in person and
informed in writing of the field trial. The information supplied to these landowners shall
include a description of the field trials, warnings of the risks to livestock, domestic
animals and children who may trespass on the trial site, and the dates on which the bait
will be applied to, and removed from, the trial site.
11. For the duration of the trial while bait in present in the forest plantation, warning signs
shall be placed at each entrance.
12. The substance shall only be used in bait stations at the trial site. The stations used shall be
designed to prevent access to the bait by birds and other non-target species.
13. Any labelling that is used on bait stations containing the bait “Cholcalciferol Fruit Jubes”,
shall not be labelled with any references to “fruit jubes”.
ERMA New Zealand Decision: Application HSC04039
Page 7 of 8
14. At the end of the trial remaining bait shall be removed from the bait stations and returned
to Pest-Tech, where it shall be kept in a lockable toxins store and subsequently disposed
of. Disposal of the bait will be carried out by Dakins, a company nominated by the
applicant.
15. Persons manufacturing and handling the baits shall wear chemical resistant gloves.
16. Persons applying the baits shall hold an Approved Handler qualification. However, the
baits may be applied by a person who is not an approved handler if:
 an approved handler is present at the facility where the baits are being handled,
and
 the approved handler has provided guidance to the person in respect of handling,
and
 the approved handler is available at all times to provide assistance if necessary.
17. The manufactured baits shall not be offered for sale.
18. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing (by letter, fax
or email) of the start and completion of the trial. Notifications shall include the following
details:
Substance name
ERMA Application number
ERMA Approval numbers
ERMA Applications Advisor
Cholcalciferol Polymer
Cholcalciferol Fruit Jubes
HSC04039
HSC000147
HSC000146
Nicola Reeves
19. If for any reason a breach of containment occurs, Pest-Tech Ltd shall notify OSH 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 waterways and/or land, the relevant
iwi authorities in the region be advised. This action should include advising them of the
contamination and the measures taken in response.
20. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
21. This approval remains in place for 2 years.
ERMA New Zealand Decision: Application HSC04039
Page 8 of 8