ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
29 April 2005
Application Code
HSC05007
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
Fort Dodge New Zealand Limited
Purpose of the Application
To enable a study to be carried out to demonstrate the
efficacy of experimental anthelmintic formulations
against natural parasite infections in cattle under New
Zealand conditions.
Date Application Received
30 March 2005
Consideration Date
29 April 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 substance Moxidectin A
Pour-On 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 (the Methodology).
1.2
The substance has been given unique identifier for the ERMA New Zealand Hazardous
Substances Register as follows:
Moxidectin A Pour-On
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.
ERMA New Zealand Decision: Application HSC05007
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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 30 March 2005.
3.2
Project Team:
Emma Doust
Applications Adviser (Hazardous Substances)
Sue Scobie
Senior Adviser (Hazardous Substances)
Linda Robinson
Manager, Māori
Report review and sign-out by:
Beth Dye
Team Leader, 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 New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls and given the
opportunity to comment on them. The comments received were taken into
consideration when the controls were finalised.
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).
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
ERMA New Zealand Decision: Application HSC05007
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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 enable a study to be carried out to demonstrate the
efficacy of experimental anthelmintic formulations against natural parasite infections in
cattle under New Zealand conditions.
4.4
As the purpose amounts to “research and development on any hazardous substance”, I
consider that the application qualifies for consideration under section 30(ba) of the Act.
Hazardous Properties
4.5
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.
4.6
The applicant has assessed the available information and has identified that the
hazardous properties are limited to acute oral toxicity, skin and eye irritancy and
aquatic ecotoxicity.
4.7
I have reviewed the applicant’s hazard information and consider that it is sufficient to
describe the hazards associated with the substance to ensure that any risks can be
managed by the containment controls.
Life Cycle
4.8
Fort Dodge New Zealand Ltd plans to import a total of 500mL of Moxidectin A PourOn. The substance will be manufactured in USA and shipped to New Zealand, where it
will be stored at the Fort Dodge Offices until the trials are ready to commence.
4.9
It will then be transported to the trial site where it will be stored in secure facilities until
required for treatment of the animals where it will be applied using a disposable
syringe.
4.10
Any leftover substance will be returned to the secure facility of the trial investigator,
and at the conclusion of the trial all remaining substance and packaging will be returned
to Fort Dodge New Zealand for disposal by an approved method.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential
risks of release from containment under the headings of environmental, human health
and welfare and Māori issues and concerns.
4.12
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.
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Risks to the Environment
4.13
If released into waterways, the substance has the potential to result in adverse effects on
aquatic organisms.
4.14
On the basis of the lifecycle of the substance outlined in paragraphs 4.8-4.10, adverse
effects could arise from:
 An accident during storage, use or transportation, resulting in release of the
substance
 Failure to follow correct disposal procedures as outlined in the Management Plan.
4.15
I consider that, taking into account the properties of the substance, the quantity
involved, the containment regime proposed by the applicant, the containment controls
in Appendix 1 and controls in place under other legislation, there are no significant
risks to the environment.
Risks to Human Health and Welfare
4.16
If the substance is ingested or contact eyes or skin, the substance can result in adverse
effects on human health and welfare.
4.17
On the basis of the lifecycle of the substance outlined in paragraphs 4.8-4.10, adverse
effects could arise from:
 An accident during storage, use or transportation, resulting in release of the
substances
 Failure to follow correct disposal procedures as outlined in the Management Plan.
4.18
I consider that, taking into account the properties of the substance, the quantity
involved, the containment regime proposed by the applicant, the containment controls
in Appendix 1 and controls in place under other legislation, there are no significant
risks to human health and welfare.
Māori issues and concerns
4.19
I have considered the potential Māori cultural effects of this application in accordance
with sections 6(d) and 8 of the HSNO Act, and the assessment framework contained in
the ERMA New Zealand User Guide “Working with Māori under the HSNO Act
1996”.
4.20
If the substance was released into the environment, and more particularly into
waterways, it is likely to have an adverse effect on aquatic taonga species and therefore
to the mauri of those aquatic environments. However, the standard and suggested
controls proposed for the trial will mitigate any effect of unintended release to
acceptable levels.
4.21
From the information provided, and considering that the application is for a
containment trial, I consider that it is unlikely to have a significant impact on the
relationship of Māori culture and traditions with Māori ancestral lands, water, sites,
waahi tapu, valued flora and fauna and other taonga.
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4.22
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.
4.23
I consider that there is no requirement for the applicant to consult with Māori regarding
this application.
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
 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
substance
 To control the effects of any accidental release of the substance
 Inspection and monitoring requirements
 Qualifications required of the person responsible for implementing the controls
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, Moxidectin A Pour-On can be adequately
contained.
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 Moxidectin A Pour-On, I
am satisfied that the controls imposed, including those in place under other legislation,
will result in the substance 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.
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6.5
The application to import into containment the hazardous substance Moxidectin A
Pour-On is thus approved pursuant to section 32 of the Act, with controls as set out in
Appendix 1.
Bas Walker
Date 29 April 2005
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
Moxidectin A Pour-On:
HSC000153
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Appendix 1: List of controls that apply to the
hazardous substance Moxidectin A Pour-On
1. The trials shall be undertaken in accordance with the Management Plan which
accompanied the application. Modifications of the Management Plan 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 substance shall be applied to the animals in appropriate cattle yards. The trial shall
be conducted in such a way as to prevent the substance entering any surface water or
groundwater system.
4. Access to the trial site shall be by permission of the Trial Director1 or owner of the
property on which it is located. The primary access points shall be signed indicating that
unauthorized access is not allowed and that a trial is being conducted on the site.
5. The substance shall be stored in accordance with good practice. This would generally be
achieved through compliance with the Code of Practice for the Management of
Agrichemicals NZS8409.
6. The substance 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. MSDS for the
substance shall accompany each shipment.
7. The substance shall be transported in accordance with good practice. This may require
compliance with the Land Transport Rule: Dangerous Goods 1999.
8. Moxidectin A Pour-On shall be applied to the skin along the back of the animals using
standard methods with a disposable syringe. The equipment used shall be sealed in a bag
and disposed of via incineration.
9. The following withholding periods shall apply to the treated animals: 91 days for meat,
and 35 days for milk.
10. Surplus substance remaining at the end of the trials shall be returned to Fort Dodge New
Zealand Ltd for secure storage in an exempt laboratory, exported or disposed of by an
approved method (note that once the trials are completed the substance does not have
approval to be present in New Zealand except in an exempt laboratory).
11. Any accidental spillage of the substance shall be contained, prevented from entering
waterways, and absorbed with an appropriate absorbent material. This material shall be
1
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of
the trial in accordance with the Management Plan and approval controls.
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placed in sealed containers and disposed of at an appropriate waste disposal facility
(which may include a landfill), subject to the facility’s waste acceptance policy.
12. A record shall be kept of all use of the substance. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Class 6, 8 and 9 Controls)
Regulations 2001.
13. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s ecotoxic and toxic properties shall accompany the substance at all stages of
its lifecycle. Safety glasses, gloves and protective clothing shall be worn when handling
the substance throughout its lifecycle.
14. 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 location, start, and completion of the trials. Notifications shall include
the following details:
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Adviser
Moxidectin A Pour-On
HSC05007
HSC000153
Emma Doust
15. If for any reason a breach of containment occurs, the Trial Director 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 a waterway, the relevant iwi
authorities be advised.
16. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
17. 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.
18. The maximum total quantity that shall be imported under this approval is 500mL of
Moxidectin A Pour-On.
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