ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
10 August 2006
Application Code
HSC06015
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Elanco Animal Health
Level 1, 123 Ormiston Road
Botany Junction
Purpose of the Application
Auckland
T9CNZ0102: To import T9CNZ0102 for use in product
development field trials for an ectoparasiticide for use in
sheep and cattle (field trial)
Date Application Received
19 July 2006
Consideration Date
10 August 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 T9CNZ0102 is
approved with controls in accordance with the relevant provisions of the Hazardous
Substances and New Organisms Act 1996 (the 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:
T9CNZ0102
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the Act. The decision was
determined in accordance with section 32, taking into account additional matters to be
considered in that section and matters as specified under Part II of the Act and the
provisions of Part III of the Third Schedule of the Act. Unless otherwise stated,
references to section numbers in this decision refer to sections of the 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 19 July 2006.
3.2
Project Team:
Beth Dye
Applications Manager (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Zack Bishara
Advisor (Māori Unit)
Report review and sign-out by:
Noel McCardle
Senior Advisor (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
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for T9CNZ0102 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 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
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.
ERMA New Zealand Decision: Application HSC06015
Page 2 of 9
Purpose of the Application
4.3
The purpose of the application is to import into containment T9CNZ0102, an
ectoparasiticide containing the active spinosad for the control of lice in cattle and sheep,
to conduct field trials to evaluate the efficacy, safety and residue profile of the
substance. T9CNZ0102 has previously had a containment approval (application
HSC02002) for the conduct of field trials. However the approval period has expired,
and further trials are required to complete the data necessary for registration of the
substance under the Agricultural Compounds and Veterinary Medicines Act 1997.
Therefore the applicant has applied for a second containment approval to complete the
trials.
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
T9CNZ0102 will be manufactured in Australia, and imported into New Zealand in the
finished product packaging. The applicant proposes to import a maximum of 1000
litres in 5 and/or 20 litre containers. It will be stored at the Elanco contract warehouse
until the substance is used in the field trials.
4.6
Prior to a trial, the substance will be transported to the trial site where it will be locked
in a secure cupboard until required for treatment. The investigator will apply the
substance using the commercial applicator to be marketed with the product. The trials
will be conducted in sheep and cattle yards. Following treatment, treated animals will
be held at the study site for the duration of the withholding time assigned by the ACVM
Group.
4.7
At the conclusion of the trial the applicant advises that any remaining substance will be
returned to Elanco Animal Health for disposal by incineration.
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 skin and eye irritancy, sensitisation, aquatic
ecotoxicity, soil ecotoxicity and terrestrial 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.
ERMA New Zealand Decision: Application HSC06015
Page 3 of 9
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, soil environment and terrestrial 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 contacts skin or eyes 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 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.
4.18
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.
ERMA New Zealand Decision: Application HSC06015
Page 4 of 9
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 4)
 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 9)
 To control the effects of any accidental release of the substance (for example,
control 13)
 Inspection and monitoring requirements (for example, control 20)
 Qualifications required of the person responsible for implementing the controls (for
example, control 11).
5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, T9CNZ0102 can be adequately contained.
ERMA New Zealand Decision: Application HSC06015
Page 5 of 9
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 T9CNZ0102, 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 T9CNZ0102 is
thus approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
Rob Forlong
Date 10 August 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
T9CNZ0102: HSC000241
ERMA New Zealand Decision: Application HSC06015
Page 6 of 9
Appendix 1: List of controls that apply to the
hazardous substance T9CNZ0102
1. The trials shall be undertaken in accordance with the information provided by the
applicant in their application, and with the Management Plan submitted with the first
application, HSC02002. 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 treated stock 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. T9CNZ0102 shall be applied to the skin along the back of study animals using standard
methods with a commercial applicator specifically designed for the substance.w
10. Treated animals shall be held at the trial site for the duration of the withholding time as
defined in the provisional registration to be issued by the Agricultural Compounds and
Veterinary Medicines Group.
11. The personnel applying T9CNZ0102 to the test animals shall be able to demonstrate that
they have the qualifications necessary to carry out the trial. Ways of demonstrating this
would include the holding of an Approved Handler qualification. They should also 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.
ERMA New Zealand Decision: Application HSC06015
Page 7 of 9
aware of the study protocol and the controls in place in order to adequately manage the
substance.
12. 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.
13. 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.
14. Surplus substance remaining at the end of the trials shall be returned to Elanco Animal
Health 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).
15. Any equipment used shall be rinsed after use with the appropriate detergent or
decontaminant, and rinsate disposed of appropriately.
16. 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.
17. 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.
18. 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
T9CNZ0102
HSC06015
HSC000241
Beth Dye
19. 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.
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 the term of any concurrent approval required under the
Agricultural Compounds and Veterinary Medicines Act 1997, to a maximum of five
years.
ERMA New Zealand Decision: Application HSC06015
Page 8 of 9
22. The maximum total quantity of T9CNZ0102 that shall be imported under this approval is
1000 L.
ERMA New Zealand Decision: Application HSC06015
Page 9 of 9