ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
24 March 2006
Application Code
HSC06002
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Jurox New Zealand Limited
85 Gardiners Road
Purpose of the Application
Rutherford, NSW 2320
LCLR Pour-On for Sheep: to import into containment
this veterinary medicine for control of lice and fly
infestations in sheep (field trial).
Date Application Received
20 February 2006
Consideration Date
24 March 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substance LCLR Pour-On for
Sheep 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 the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
LCLR Pour-On for Sheep
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 HSNO 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 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 20 February 2006.
3.2
Project Team:
Nicola Reeves
Applications Advisor (Hazardous Substances)
Chris Geering
Science Advisor (Hazardous Substances)
Peter Jackson
Advisor (Māori Unit)
Report review and sign-out by:
Noel McCardle
Applications Team Leader (Hazardous
Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices including formulation information.
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 (Workplace Group)
 The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
A response was received from the ACVM Group stating that “as this application will be
considered under the ACVM Act, any issues which may arise under the Acts
administered by MAF/NZFSA will be considered as part of that application.”
3.6
The applicant was provided with a copy of the proposed controls for LCLR Pour-On for
Sheep and given the opportunity to comment on them. The applicant advised that they
did not have any objections to the proposed controls.
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 HSNO Act, the approach adopted when
considering this application was to confirm whether the application was for one of the
ERMA New Zealand Decision: Application HSC06002
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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 HSNO Act.
Purpose of the Application
4.3
The purpose of the application is to import into containment LCLR Pour-On for Sheep,
an ectoparasiticide for the control of lice and fly infestations, to conduct field trials to
evaluate the efficacy of the substance in sheep.
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
HSNO Act.
Life Cycle
4.5
LCLR Pour-On for Sheep will be imported into New Zealand in packaging labelled
with instructions concerning directions for use, safety directions for users, first aid
statements and environmental precautions. After importation into New Zealand the
LCLR Pour-On for Sheep will be stored with a contract researcher until the substance is
used in the field trials.
4.6
The applicant proposes to test a maximum of 30 L of LCLR Pour-On for Sheep in a
replicated field trial consisting of five sites. It is likely that 3 x 10 L packs will be
dispatched from Australia. In the field trial the substance will be applied to the sheep as
a dip or along the backline. The substance will be applied to the test animals as a onceonly treatment. The substance will be retained on the wool of the animals where it acts
to control lice and fly infestations. Treated sheep will be confined with the trial area. A
maximum dose of 7 mL of LCLR Pour-On for Sheep will be applied per sheep and a
maximum of 4500 sheep with be treated in the trial.
4.7
The contract researcher will return any unused substance in the original containers to
Jurox in Australia for disposal.
Hazardous Properties
4.8
I note that a containment application requires only sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls.
4.9
The applicant has examined the properties of the components, and considers that the
substance will trigger thresholds for acute toxicity. I note that the substance will also
trigger thresholds for target organ systemic toxicity, and aquatic eoctoxicity and
terrestrial vertebrate and invertebrate ecotoxicity.
4.10
I have reviewed the applicant’s hazard information and I consider that the information
is sufficient for me to determine that any risks can be managed by the containment
controls.
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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 escape 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.
Risks to the Environment
4.13
If released off target, the substance has the potential to cause adverse effects to the
aquatic environment and terrestrial vertebrates and invertebrates.
4.14
On the basis of the lifecycle of the substance outlined in paragraph 4.5 to 4.7, adverse
effects could arise from:
 An accident during storage, use or transportation, resulting in release of the
substance,
 Failure to dispose of the substance in the manner proposed by the applicant,
 Failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance.
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. I consider that the controls in place are not too onerous to be
complied with and therefore the risks to the environment are negligible.
Risks to Human Health and Welfare
4.16
If the substance is ingested there is the potential to cause adverse effects on human
health.
4.17
On the basis of the lifecycle of the substance outlined in paragraphs 4.5 and 4.7,
adverse effects could arise from:
 An accident during storage, use or transportation, resulting in release of the
substance,
 Failure to dispose of the substance in the manner proposed by the applicant,
 Failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance.
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. I consider that the controls in place are not too
onerous to be complied with and therefore the risks to human health and welfare are
negligible.
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Māori issues and concerns
4.19
I have considered the potential Māori cultural effects of this application in accordance
with the Methodology clauses 9(b)(i) and 9(c)(iv) and 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
I note that the substance has hazardous properties that trigger HSNO toxicity and
ecotoxicity thresholds. There is the potential for this substance to have a negative
impact on Māori and the mauri of iwi, cultural tāonga and the environment.
4.21
I am unaware of any impacts that the substance could have on Māori culture, or, on
traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and
fauna or other taonga. I have no evidence to suggest that the controlled containmenttrial use of the substance will breach the principles of the Treaty of Waitangi and see no
requirement for the applicant to consult with Māori regarding this application.
4.22
This assessment is made on the condition that the substance is handled, stored,
transported, used and disposed of, in accordance with the explicitly stated 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 the appropriate authorities be notified 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
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 substance or
contamination by hazardous substances (for example, control 6)
 To exclude organisms from a facility (for example, control 5)
 To exclude unauthorized people from the facility (for example, control 4)
 To prevent unintended release of the substance by experimenters working with the
substance (for example, control 8)
 To control the effects of any accidental release of the substance (for example,
control 14)
 Inspection and monitoring requirements (for example, control 23)
 Qualifications required of the person responsible for implementing the controls (for
example, control 12).
5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, LCLR Pour-On for Sheep can be adequately
contained.
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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 a purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of LCLR Pour-On for Sheep, 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 substance;
 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 substance LCLR Pour-On for
Sheep is thus approved pursuant to section 32 of the Act, with controls as set out in
Appendix 1.
Rob Forlong
Date 24 March 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
LCLR Pour-On for Sheep: HSC000230
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Appendix 1: List of controls that apply to the
hazardous substance LCLR Pour-On for Sheep
1. The trials shall be undertaken in accordance with the information provided by the
applicant in their application. Modification of this information 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 yard areas. 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 sites shall be by permission of the Trial Director1 or owner of the
property on which it is located. The trial site boundaries shall be clearly marked and
distinctly visible from outside the trial site throughout the life of the trials. The trial sites
shall be signed indicating that unauthorized access is not allowed, that the site is subject
to a trial, and that the sheep should not be removed.
5. The substance shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004.
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. A Safety Data Sheet
shall accompany each shipment.
7. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005.
8. The substance shall be mixed, diluted and prepared in any other way prior to application
in accordance with the relevant sections of the Code of Practice for the Management of
Agrichemicals NZS 8409: 2004.
9. LCLR Pour-On for Sheep shall be applied by sheep as a dip or by application along the
back line standard methods. After use, equipment used for application of the substance
shall be sealed in a bag and disposed of via incineration.
10. Treated animals shall be confined in the trial area as defined in the provisional
registration to be issued by the Agricultural compounds and Veterinary Medicines Group.
11. The Trial Director shall ensure that the trial sites are inspected on a daily basis
12. The personnel applying LCLR Pour-On for Sheep to the test animals shall be able to
demonstrate that they have the qualifications necessary to carry out the trial. Ways of
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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demonstrating this would include the holding of an Approved Handler qualification. They
should also be aware of the study protocol and the controls in place in order to adequately
manage the substance.
13. Any treated animal intended for human or animal consumption, or offered for sale shall
comply with any withholding period and maximum residue levels set by the New Zealand
Food Safety Authority.
14. Any accidental spillage of the substance shall be contained, prevented from entering
waterways, and absorbed with an appropriate absorbent material. This material shall be
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.
15. The amount of dilute LCLR Pour-On for Sheep prepared shall be adequate for number of
animals to be treated, but if there is any surplus dilute LCLR Pour-On for Sheep it shall
be disposed by returning to Jurox Australia.
16. Surplus substance remaining at the end of the trials shall be returned to Jurox in Australia
for disposal (note that once the trials are completed the substance does not have approval
to be present in New Zealand except in an exempt laboratory).
17. Any equipment used shall be rinsed after use with the appropriate detergent or
decontaminant, and rinsate disposed of appropriately.
18. Any accidental spillage of concentrated LCLR Pour-On for Sheep or dilute LCLR PourOn for Sheep prepared for dosing shall be contained, prevented from entering waterways,
and absorbed with an appropriate absorbent material. This material shall be placed into
sealed containers and disposed of at an appropriate waste disposal facility (which may
include a landfill), subject to the facility’s waste acceptance policy.
19. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s toxic and ecotoxic properties shall accompany the substance at all stages of
its lifecycle. Personal protective equipment shall be worn when handling the substance
during the use stage of the lifecycle.
20. 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 (Classes 6, 8 and 9 Controls)
Regulations 2001.
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
ERMA New Zealand Decision: Application HSC06002
LCLR Pour-On for Sheep
HSC05026
HSC000230
Nicola Reeves
Page 8 of 9
22. 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.
23. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
24. 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.
25. The maximum total quantity of LCLR Pour-On for Sheep that shall be imported under
this approval is 40 L.
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